Uveitic Macular EdemaPhase 3SandcatNCT05642325
Vamikibart in Participants With Uveitic Macular Edema
A Phase 3 study testing Vamikibart in people with Uveitic Macular Edema, run by Hoffmann-La Roche at 94 sites in 19 countries.
Trial summary
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitic Macular Edema
- What is being tested?
- Vamikibart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 256 participants
- Where
- 94 sitesin 19 countries
- Study dates
- 23 Mar 2023to 24 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
- Diagnosis of macular edema associated with non-infectious uveitis (NIU)
- Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
- BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
Who cannot join
- Evidence of active or latent syphilis infection
- Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
- Serious acute or chronic medical or psychiatric illness
- History of major ocular and non-ocular surgical procedures
- Uncontrolled IOP or glaucoma or chronic hypotony
- Any anatomical changes or media opacity in the study eye preventing evaluation of retina, vitreous, and capture of study images
Show all 11Show fewer
- Prior use of IVT biologics including anti-VEGFs less than 2-4 months prior to Day 1; received IVT Methotrexate within 4 months prior to Day 1
- Prior macular laser therapy, cataract surgery within 6 months and laser capsulotomy within 3 months of Day 1
- Topical corticosteroids and/or topical NSAID > 3 drops per day in the 14 days prior to Day 1 (D1); intraocular or periocular corticosteroid injections in the 2 months prior to D1; subconjunctival corticosteroid injection within 1 month prior to Day 1; an OZURDEX implant in the 4 months prior to D1; YUTIQ, RETISERT or ILUVIEN implant in the 3 years prior to D1
- Diagnosis of macular edema due to any cause other than NIU
- Any major ocular conditions that may require medical or surgical intervention during the study period to prevent vision loss
Trial locations and contacts
94 sites in 19 countries.
94 sites in 19 countries
United States23 sites
Retina Research Institute of Texas
Abilene, Texas, 79606
University of Michigan, Kellogg Eye Center
Ann Arbor, Michigan, 48105
Retina Consultants of Texas
Bellaire, Texas, 77401
Cleveland Clinic
Cleveland, Ohio, 44195
Advanced Research
Deerfield Beach, Florida, 33064
Duke Eye Center
Durham, North Carolina, 27710
Erie Retina Research
Erie, Pennsylvania, 16507-1429
Retina Group of Washington
Fairfax, Virginia, 22031
Retina Group of Florida
Fort Lauderdale, Florida, 33308
Retina Consultants of Orange County
Fullerton, California, 92835
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740
Retina Consultants of Texas
Katy, Texas, 77494
University of Wisconsin
Madison, Wisconsin, 53705
Northern California Retina Vitreous Associates
Mountain View, California, 94040
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452
California Eye Specialists Medical group Inc.
Pasadena, California, 91107
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
Associated Retina Consultants
Phoenix, Arizona, 85020
Retina Consultants of Southern California
Redlands, California, 92374
Kaiser Permanente Riverside Medical Center
Riverside, California, 92505
University of California, Davis, Eye Center
Sacramento, California, 95817
Retinal Consultants Med Group
Sacramento, California, 95825
Barnet Dulaney Perkins Eye Center
Sun City, Arizona, 85351
Japan14 sites
Kyushu University Hospital
Fukuoka, 812-8582
Hiroshima University Hospital
Hiroshima, 734-8551
Hokkaido University Hospital
Hokkaido, 060-8648
Kobe University Hospital
Hyōgo, 650-0017
Kagoshima University Hospital
Kagoshima, 890-8520
Yokohama City University Hospital
Kanagawa, 236-0004
Japan Community Health care Organization Osaka Hospital
Osaka, 553-0003
The University of Osaka Hospital
Osaka, 565-0871
Jichi Medical University Saitama Medical Center
Saitama, 330-0834
National Defense Medical College Hospital
Saitama, 359-8513
Tokyo Medical University Hospital
Tokyo, 160-0023
Kyorin University Hospital
Tokyo, 181-8611
Nippon Medical School Tama Nagayama Hospital
Tokyo, 206-8512
Yamaguchi University Hospital
Yamaguchi, 755-8505
Germany10 sites
Charité-Universitätsmedizin Berlin, Campus Virchow Klinikum
Berlin, 13353
Universitatsklinikum Koln
Cologne, 50937
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106
Universitätsmedizin Göttingen Georg-August-Universität
Göttingen, 37075
Universitatsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinik Heidelberg
Heidelberg, 69120
Universitätskliniikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
St. Franziskus Hospital
Münster, 48145
Knappschaftsklinikum Saar GmbH
Sulzbach, 66280
Universitäts-Augenklinik Tübingen
Tübingen, 72076
Argentina5 sites
Centro Privado de Ojos
Ciudad Autonoma Buenos Aires, C1033AAW
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE
Consultorios Medicos Oftalmológicos
Ciudad Autonoma Buenos Aires, C1426DQS
Oftalmologia Global
Rosario, 2000
Organizacion Medica de Investigacion
San Nicolás, C1015ABO
Australia5 sites
Centre For Eye Research Australia
East Melbourne, Victoria, 3002
Eye Surgery Associates
Malvern, Victoria, 3144
The Lions Eye Institute
Nedlands, Western Australia, 6009
Retina Specialists Victoria
Rowville, Victoria, 3178
Sydney Eye Hospital
Sydney, New South Wales, 2000
India5 sites
Narayana Nethralaya Hospital
Bangalore, Karnataka, 560010
Postgraduate Institute of Medical Education and Research
Chandigarh, 160012
Sankara Nethralaya
Chennai, Tamil Nadu, 600006
L V Prasad Eye Institute
Hyderabad, Telangana, 500034
ICARE Eye Hospital & PG Institute
Noida, Uttar Pradesh, 201301
Spain5 sites
Hospital de Cruces
Barakaldo, Vizcaya, 48903
Hospital Clinic Barcelona
Barcelona, 08036
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 8907
Fundacion Jimenez Diaz-UTE
Madrid, 28040
Hospital Clinico San Carlos
Madrid, 28040
France4 sites
CHU Nantes - Hotel Dieu
Nantes, 44093
Hopital Lariboisiere
Paris, 75010
Hôpital COCHIN
Paris, 75014
Ch Pitie Salpetriere
Paris, 75651
Switzerland4 sites
Inselspital Bern Ophthalmologische Klinik
Bern, 3010
Berner Augenklinik
Bern
Vista Klinik Ophthalmologische Klinik
Binningen, 4102
Stadtspital Triemli Ophthalmologische Klinik
Zurich, 8063
China3 sites
Peking Union Medical College Hospital
Beijing, 100032
Beijing Tongren Hospital
Beijing, 100730
The First Affiliated Hospital, Chongqing Medical University
Chongqing, 400016
Italy3 sites
Irccs Ospedale San Raffaele
Milan, Lombardy, 20132
Asst Fatebenefratelli Sacco
Milan, Lombardy, 20157
AUSL ? IRCCS Santa Maria Nuova
Reggio Emilia, Emilia-Romagna, 42100
South Korea3 sites
Pusan National University Hospital
Busan, 602-739
Kyung Hee University Hospital
Seoul, 02447
Seoul National University Hospital
Seoul, 03080
Portugal2 sites
AIBILI - Association for Innovation and Biomedical Research on Light
Coimbra, 3000-548
Hospital de Santa Maria
Lisbon, 1649-035
Taiwan2 sites
Taipei Veterans General Hospital
Taipei, 11217
Chang Gung Medical Foundation - Linkou
Taoyuan, 333
Turkey (Türkiye)2 sites
Hacettepe University Medical Faculty
Ankara, 06100
Ege Üniversitesi Tip Fakültesi
Lzmir, 35100
Kazakhstan1 site
"Kazakh "Badge of H?nour" Scientific R?s??r?h Institute of ??? diseases" LLP
Almaty, 050012
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London, EC1V 2PD
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
- Conditions
- Uveitic Macular Edema
- Being tested
- Vamikibart, Sham
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VamikibartDrug
Also called RO7200220
Participants will receive vamikibart IVT injection
ShamOther
Participants will receive a sham procedure that mimics an IVT injection.
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Participants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. Receives: Drug: Vamikibart |
| Arm B | Experimental | Participants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. Receives: Drug: Vamikibart |
| Arm C | Sham comparator | Participants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. Receives: Other: Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Measured: Week 16
Secondary outcomes (21)
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Measured: Week 20
Change from baseline in BCVA at Week 16
Measured: Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Measured: Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Measured: Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Measured: Weeks 20 and 52
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Measured: Weeks 16 and 52
Time to rescue treatment
Measured: Up to Week 52
Number of rescue treatments received
Measured: Up to Week 52
Type of rescue treatments received
Measured: Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Measured: Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Measured: Weeks 16 and 52
Time to first PRN injection
Measured: Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Measured: Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Measured: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Measured: Week 24
Percentage of participants with non-ocular AEs
Measured: Up to Week 52
Percentage of participants with adverse events of special interest (AESIs)
Measured: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Measured: Week 52
Aqueous humor (AH) concentration of vamikibart
Measured: Up to Week 52
Serum concentration of vamikibart
Measured: Up to Week 52
Anti-drug antibody titer to vamikibart
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start23 Mar 2023
- Primary completion7 May 2025
- Study completion24 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 256 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-LaRoche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642325
- Sponsor's protocol ID
- GR44278
- Other IDs
- 2022-501794-39-00
- Acronym
- Sandcat
- Status last verified
- Apr 2026
- First submitted
- 6 Dec 2022
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Masked, Sham-Controlled Study to Investigate the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Vamikibart Administered Intravitreally in Patients With Uveitic Macular Edema
- ClinicalTrials.gov ID
- NCT05642325
- Acronym / sponsor ID
- Sandcat / GR44278
- Conditions
- Uveitic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 24 Dec 2025 (actual)
- First posted
- 8 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the efficacy and safety of vamikibart in participants with uveitic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: VamikibartParticipants will receive 4 high-dose vamikibart intravitreal (IVT) injections every 4 weeks (Q4W) to Week 12, followed by as-needed (PRN) dosing from Week 20 to Week 48. |
| Arm B | Experimental | Drug: VamikibartParticipants will receive 4 low-dose vamikibart IVT injections Q4W to Week 12, followed by PRN dosing from Week 20 to Week 48. |
| Arm C | Sham comparator | Other: ShamParticipants will receive 4 sham injections Q4W to Week 12, followed by PRN sham dosing from Week 20 to Week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Female participants: Agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception as defined by the protocol
- Diagnosis of macular edema associated with non-infectious uveitis (NIU)
- Diagnosis of active or inactive, acute, or chronic NIU of any etiology and of any anatomical type (anterior, intermediate, posterior, panuveitis)
- BCVA letter score of 73 to 19 letters (inclusive) on Early Treatment Diabetic Retinopathy Study (EDTRS)-like charts
Key exclusion criteria (11 listed)
- Evidence of active or latent syphilis infection
- Evidence of active or latent tuberculosis infection and/or positive tuberculosis assay, or previous or current HIV diagnosis
- Serious acute or chronic medical or psychiatric illness
- History of major ocular and non-ocular surgical procedures
- Uncontrolled IOP or glaucoma or chronic hypotony
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: RO7200220Participants will receive vamikibart IVT injection | Drug | Arm A, Arm B |
| ShamParticipants will receive a sham procedure that mimics an IVT injection. | Other | Arm C |
Primary outcome
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16
Time frame: Week 16
21 secondary outcomes
Proportion of participants with ≥ 15 letter improvement from baseline in BCVA at Week 20
Time frame: Week 20
Change from baseline in BCVA at Week 16
Time frame: Week 16
Change from baseline in central subfield thickness (CST) at Week 16
Time frame: Week 16
Change from Baseline in BCVA at Weeks 20 and 52
Time frame: Weeks 20 and 52
Change from baseline in CST at Weeks 20 and 52
Time frame: Weeks 20 and 52
Proportion of participants with uveitic macular edema secondary to non-infectious uveitis (UME) resolution defined by standardized (by machine) CST threshold <325um on optical coherence tomography (OCT) from baseline at Weeks 16 and 52
Time frame: Weeks 16 and 52
Time to rescue treatment
Time frame: Up to Week 52
Number of rescue treatments received
Time frame: Up to Week 52
Type of rescue treatments received
Time frame: Up to Week 52
Proportion of participants with ≥15 letter improvement from baseline in BCVA at Week 16 and 52
Time frame: Weeks 16 and 52
Proportion of participants without ≥15 letter loss from baseline in BCVA at Week 16 and 52
Time frame: Weeks 16 and 52
Time to first PRN injection
Time frame: Up to Week 52
Change from baseline in the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) at Weeks 16 and 52
Time frame: Weeks 16 and 52
Percentage of participants with ocular adverse events (AEs)
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 24
Time frame: Week 24
Percentage of participants with non-ocular AEs
Time frame: Up to Week 52
Percentage of participants with adverse events of special interest (AESIs)
Time frame: Up to Week 52
Percent change from baseline in corneal endothelial cell density at Week 52
Time frame: Week 52
Aqueous humor (AH) concentration of vamikibart
Time frame: Up to Week 52
Serum concentration of vamikibart
Time frame: Up to Week 52
Anti-drug antibody titer to vamikibart
Time frame: Baseline to Week 52
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
- 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-LaRoche
94 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Vamikibart in people with Uveitic Macular Edema, run by Hoffmann-La Roche at 94 sites in 19 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 4 inclusion and 11 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 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 94 sites in United States, Japan, Germany, Argentina, Australia and 14 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants with ≥ 15 letter improvement from baseline in best-corrected visual acuity (BCVA) at Week 16 (time frame: Week 16). 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 17 Apr 2026.