Diabetic Macular EdemaPhase 2NCT05151731
A Study to Investigate Vamikibart (RO7200220) in Diabetic Macular Edema
A Phase 2 study testing Vamikibart and Ranibizumab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 74 sites in 9 countries.
Trial summary
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Vamikibart and Ranibizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 394 participants
- Where
- 74 sitesin 9 countries
- Study dates
- 31 Dec 2021to 21 Apr 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Willingness to allow Aqueous Humor collection
- For women of childbearing potential: agreement to remain abstinent or use at least one highly effective contraceptive method that results in a failure rate of <1% per year during the treatment period and for at least 12 weeks after the final dose of study treatment
Who cannot join
- Hemoglobin A1c (HbA1c) of greater than (>) 12%
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Prior treatment with panretinal photocoagulation or macular laser to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
- Prior Iluvien or Retisert implants within 3 years prior to Day 1 to the study eye
Show all 13Show fewer
- Prior or concomitant treatment with anti-VEGF therapy within 8 weeks prior to Day 1 to the study eye; Vabysmo^TM within 16 weeks prior to Day 1, prior Beovu® is not permitted
- Prior administration of IVT brolucizumab (Beovu®): ever; vamikibart: </=24 weeks prior to Day 1) in either eye
- Any proliferative diabetic retinopathy
- Active intraocular or periocular infection or active intraocular inflammation in the study eye
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
- Other protocol-specified inclusion/exclusion criteria may apply
Trial locations and contacts
74 sites in 9 countries.
74 sites in 9 countries
United States36 sites
Win Retina
Arcadia, California, 91006
Texas Retina Associates
Arlington, Texas, 75075
Western Carolina Retinal Associate PA
Asheville, North Carolina, 28803
Austin Clinical Research LLC
Austin, Texas, 78750
Retina Consultants of Texas
Bellaire, Texas, 77401
Meridian Clinical Research
Cincinnati, Ohio, 45219
Rand Eye
Deerfield Beach, Florida, 33064
Erie Retinal Surgery
Erie, Pennsylvania, 16507
Verum Research LLC
Eugene, Oregon, 97401
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740
Eye Care Specialists, PC
Kingston, Pennsylvania, 18704
Charleston Neuroscience Institute
Ladson, South Carolina, 29456
Colorado Retina Associates, PC
Lakewood, Colorado, 80228
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Opthalmic Consultants of LI
Lynbrook, New York, 11563
Piedmont Eye Center
Lynchburg, Virginia, 24502
Valley Retina Institute P.A.
McAllen, Texas, 78503
Retina Consultants of Nashville
Nashville, Tennessee, 37203
Wagner Macula & Retina Center
Norfolk, Virginia, 23502
Florida Retina Institute
Orlando, Florida, 32806-1101
EyeHealth Northwest
Portland, Oregon, 97225
Retina Consultants, San Diego
Poway, California, 92064
Black Hills Eye Institute
Rapid City, South Dakota, 57701
Sierra Eye Associates
Reno, Nevada, 89502
University of Rochester Flaum Eye Institute
Rochester, New York, 14642
Retinal Consultants Med Group
Sacramento, California, 95825
Sewickley Eye Group
Sewickley, Pennsylvania, 15143
Deep Blue Retina PLLC
Southaven, Mississippi, 38671
Retina Vitreous Associates of Florida
St. Petersburg, Florida, 33607
Retina Consultants of Texas
The Woodlands, Texas, 78240
Bay Area Retina Associates
Walnut Creek, California, 94598
Emerson Clinical Research Institute LLC
Washington D.C., District of Columbia, 20011-3010
Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
Argentina9 sites
Organizacion Medica de Investigacion
Buenos Aires, C1015ABO
Centro Oftalmologico Dr. Charles S.A.
Capital Federal, C1116
Oftalmos
Capital Federal, C1120AAN
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE
Centro Privado de Ojos Romagosa
Córdoba
Centro de ojos Loria
Lomas de Zamora
Oftar
Mendoza, M5500GGK
Microcirugía Ocular S.A
Rosario, S2000CTC
Grupo Laser Vision
Rosario, S2000DLA
Poland7 sites
Niepubliczny Zak?ad Opieki Zdrowotnej PRYZMAT-OKULISTYKA
Gliwice, 44-100
Uniwersyteckie Centrum Kliniczne
Katowice, 40-514
Centrum Medyczne UNO-MED
Krakow, 31-070
SPSK nr 1 w Lublinie
Lublin, 20-079
Centrum Diagnostyki i Mikrochirurgii Oka LENS
Olsztyn, 10-424
LensClinic
Rybnik, 44-203
Caminomed
Tarnowskie Góry, 42-600
South Korea5 sites
Yeungnam University Medical Center
Daegu, 42415
Seoul National University Bundang Hospital
Seongnam-si, 13605
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Kim's Eye Hospital
Seoul, 07301
United Kingdom5 sites
Bristol Eye Hospital
Bristol, BS1 2LX
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, GL1 3NN
Royal Surrey County Hospital
Guildford, GU2 7XX
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP
Czechia4 sites
Faculty Hospital Ostrava
Ostrava, 708 52
Faculty Hospital Kralovske Vinohrady
Prague, 100 34
General Teaching Hospital Prague
Prague, 128 08
AXON Clinical
Prague
Spain4 sites
Oftalvist Valencia
Burjassot, Valencia, 46100
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222
Hospital General de Catalunya
Sant Cugat de Valles, Barcelona, 08190
Hospital Universitario Miguel Servet
Zaragoza, 50009
Canada3 sites
Institut De L'Oeil Des Laurentides
Boisbriand, Quebec, J7H 0E8
Retina Institute of Ottawa
Ottawa, Ontario, K2B 7E9
Toronto Retina Institute
Toronto, Ontario, M3C 0G9
Puerto Rico1 site
Emanuelli Research and Development Center LLC
Arecibo, 00612
About this study
Official title: A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
- Conditions
- Diabetic Macular Edema
- Being tested
- Vamikibart, Ranibizumab, Sham Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VamikibartDrug
Also called RO7200220
Vamikibart will be administered by IVT injection as specified in each treatment arm.
RanibizumabDrug
Also called Lucentis
Ranibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm.
Sham ProcedureOther
Sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: 0.25 mg Vamikibart Q8W | Experimental | Participants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Receives: Drug: Vamikibart; Other: Sham Procedure |
| Arm B: 1.0 mg Vamikibart Q8W | Experimental | Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. Receives: Drug: Vamikibart; Other: Sham Procedure |
| Arm C: 1.0 mg Vamikibart Q4W | Experimental | Participants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections. Receives: Drug: Vamikibart |
| Arm D: 0.5 mg Ranibizumab Q4W | Active comparator | Participants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections. Receives: Drug: Ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Secondary outcomes (28)
Number of Participants With Systemic and Ocular Adverse Events (AEs)
An AE was any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Systemic AEs include all non-ocular AEs. Only one eye was selected as the study eye, while the other was referred to as the fellow eye.
Measured: Up to Week 72
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Measured: From baseline up to Week 72
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Measured: From baseline up to Week 72
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
The BCVA, at a starting test distance of 4 m, was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified ETDRS charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 (Snellen equivalent <20/800) to 100 (Snellen equivalent of 20/10) letters. A gain in BCVA letter score from baseline indicates an improvement in visual acuity. Percentages have been summarized.
Measured: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants
CST was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE), measured using Spectral Domain-Optical Coherence Tomography (SD-OCT). This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 20 and 24
Change From Baseline in CST Over Time, in Overall Enrolled Population
CST was defined as the distance between the ILM and the RPE, measured using SD-OCT. This analysis used a MMRM model. Adjusted mean has been reported.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Absence of DME was defined as CST < 325 µm for spectralis SD-OCT, or < 315 μm for cirrus SD-OCT or topcon SD-OCT. SD-OCT was performed on a Spectralis instrument. Percentages have been summarized.
Measured: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
The absence of IRF in the study eye (defined as IRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with the absence of IRF at the foveal center were reported. Percentages have been summarized.
Measured: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
The absence of SRF in the study eye (defined as SRF absent or definite outside center subfield only) was assessed by the central reading center using SD-OCT. The percentage of participants with absence of SRF at the foveal center were reported. Percentages have been summarized.
Measured: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start31 Dec 2021
- Primary completion6 Nov 2024
- Study completion21 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 394 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151731
- Sponsor's protocol ID
- BP43445
- Other IDs
- 2021-003756-16
- Status last verified
- Apr 2026
- First submitted
- 8 Dec 2021
- Last updated
- 11 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Multicenter, Randomized, Double Masked, Active Comparator-Controlled Study to Investigate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7200220 Administered Intravitreally in Patients With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05151731
- Acronym / sponsor ID
- BP43445
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 394 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2021 (actual)
- Primary completion
- 6 Nov 2024 (actual)
- Study completion
- 21 Apr 2025 (actual)
- First posted
- 9 Dec 2021 (actual)
- Results
- Posted 11 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study BP43445 is a phase II, multicenter, randomized, double-masked, active comparator-controlled study to investigate the efficacy, safety, tolerability, pharmacokinetics, and pharmacodynamics of vamikibart administered intravitreally in participants with diabetic macular edema. Only one eye will be chosen as the study eye. The duration of the study will be up to 76 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm A: 0.25 mg Vamikibart Q8W | Experimental | Drug: Vamikibart, Other: Sham ProcedureParticipants will receive vamikibart 0.25 milligrams (mg), by intravitreal (IVT) injection, on Day 1 and every 8th week (Q8W), up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. |
| Arm B: 1.0 mg Vamikibart Q8W | Experimental | Drug: Vamikibart, Other: Sham ProcedureParticipants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and Q8W, up to Week 44, for a total of 6 injections. A sham procedure will be administered during study visits at which no study drug is administered to maintain masking between treatment arms. |
| Arm C: 1.0 mg Vamikibart Q4W | Experimental | Drug: VamikibartParticipants will receive vamikibart 1.0 mg, by IVT injection, on Day 1 and every 4th week (Q4W), up to Week 44 for a total of 12 injections. |
| Arm D: 0.5 mg Ranibizumab Q4W | Active comparator | Drug: RanibizumabParticipants will receive ranibizumab 0.5 mg, by IVT injection, on Day 1 and Q4W, up to Week 44 for a total of 12 injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of diabetes mellitus (Type 1 or Type 2)
- Macular thickening secondary to diabetic macular edema (DME) involving the center of the macula
- Decreased visual acuity attributable primarily to DME
- Ability and willingness to provide written informed consent and to comply with the study protocol
- Willingness to allow Aqueous Humor collection
Key exclusion criteria (13 listed)
- Hemoglobin A1c (HbA1c) of greater than (>) 12%
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
- Currently pregnant or breastfeeding, or intend to become pregnant during the study
- Prior treatment with panretinal photocoagulation or macular laser to the study eye
- Any intraocular or periocular corticosteroid treatment within the past 16 weeks prior to Day 1 to the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VamikibartAlso: RO7200220Vamikibart will be administered by IVT injection as specified in each treatment arm. | Drug | Arm A: 0.25 mg Vamikibart Q8W, Arm B: 1.0 mg Vamikibart Q8W, Arm C: 1.0 mg Vamikibart Q4W |
| RanibizumabAlso: LucentisRanibizumab 0.5 mg will be administered to the participants by IVT injection, as specified in the treatment arm. | Drug | Arm D: 0.5 mg Ranibizumab Q4W |
| Sham ProcedureSham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. Sham procedure will be administered to participants in the Q8W arms at applicable visits to maintain masking between treatment arms. | Other | Arm A: 0.25 mg Vamikibart Q8W, Arm B: 1.0 mg Vamikibart Q8W |
Primary outcome
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants
Time frame: Baseline, Weeks 44 and 48
The BCVA, at a starting test distance of 4 meters (m), was measured for both eyes, prior to dilating eyes by using the set of three Precision visionTM or Lighthouse distance acuity charts (modified early treatment diabetic retinopathy study [ETDRS] charts 1, 2 and R) by trained and certified personnel at the study sites and at each study visit. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. This analysis used a Mixed Model for Repeated Measurements (MMRM) model. Adjusted mean has been reported.
28 secondary outcomes
Number of Participants With Systemic and Ocular Adverse Events (AEs)
Time frame: Up to Week 72
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Previously Treated Participants
Time frame: Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 44 and Week 48, in Overall Enrolled Population
Time frame: Baseline, Weeks 44 and 48
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Treatment-naïve Participants
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Previously Treated Participants
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 32 and Week 36, in Overall Enrolled Population
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Treatment-naïve Participants
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Previously Treated Participants
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Averaged Over Week 20 and Week 24, in Overall Enrolled Population
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in BCVA Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants Gaining Greater Than or Equal to (≥) 15, ≥ 10, ≥ 5, or ≥ 0 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Time frame: From baseline up to Week 72
Percentage of Participants Avoiding a Loss of ≥ 15, ≥ 10, or ≥ 5 Letters in BCVA From Baseline Over Time, in Overall Enrolled Population
Time frame: From baseline up to Week 72
Percentage of Participants With BCVA ≥ 69 Letters (20/40 Snellen Equivalent) Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA ≥ 84 Letters (20/20 Snellen Equivalent) Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Percentage of Participants With BCVA of Less Than or Equal to (≤) 38 Letters (Snellen Equivalent 20/200) Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 1, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Change From Baseline in Central Subfield Thickness (CST) Averaged Over Weeks 44 and 48, in Treatment-naïve Participants
Time frame: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Previously Treated Participants
Time frame: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 44 and 48, in Overall Enrolled Population
Time frame: Baseline, Weeks 44 and 48
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Treatment-naïve Participants
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Previously Treated Participants
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 32 and 36, in Overall Enrolled Population
Time frame: Baseline, Weeks 32 and 36
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Treatment-naïve Participants
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Previously Treated Participants
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in CST Averaged Over Weeks 20 and 24, in Overall Enrolled Population
Time frame: Baseline, Weeks 20 and 24
Change From Baseline in CST Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of DME Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72
Percentage of Participants With Absence of Intraretinal Fluid (IRF) Over Time, in Overall Enrolled Population
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Percentage of Participants With Absence of Subretinal Fluid (SRF) Over Time, in Overall ITT Population
Time frame: Baseline, Weeks 4, 12, 24, 36, 48, and 72
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
74 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vamikibart and Ranibizumab in people with Diabetic Macular Edema, run by Hoffmann-La Roche at 74 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in United States, Argentina, Poland, South Korea, United Kingdom and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Best-Corrected Visual Acuity (BCVA) Averaged Over Week 44 and Week 48, in Treatment-naïve Participants (time frame: Baseline, Weeks 44 and 48). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.