Diabetic Macular Edema (DME)Phase 2/3BRUNELLONCT06571045
A Study to Evaluate the Efficacy and Safety of 2 Doses of Remigromig (EYE103) Compared With Ranibizumab (0.5 mg) in Participants With DME
A Phase 2/3 study testing Ranibizumab and Remigromig in people with Diabetic Macular Edema (DME), run by EyeBiotech Ltd. at 183 sites in 20 countries.
Trial summary
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME) In the first year, all 3 treatment groups will be treated every 4 weeks with either… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- Ranibizumab and Remigromig
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 183 sitesin 20 countries
- Study dates
- 7 Aug 2024to 31 Dec 2027
- Phase
- Phase 2/3
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
- Be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
- Be male or female ≥18 years of age.
- Have type 1 or type 2 diabetes mellitus and a hemoglobin A1c (HbA1c) of ≤12%.
- Have a decrease in vision in the study eye determined by the investigator to be primarily the result of diabetic macular edema (DME).
Who cannot join
- Be pregnant or breastfeeding
- History of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of Screening
- Have any treatment for complications of cataract surgery with steroids or yttrium aluminum garnet (YAG) laser capsulotomy within 90 days of Screening
- Are currently using drugs with known retinal toxicity (e.g., Hydroxychloroquine, pentosan polysulfate sodium, and amiodarone)
- If treatment-experienced for DME have a history of any of the following treatments within the noted time windows:
- Have had prior treatment in the study eye with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye
- Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit
Trial locations and contacts
183 sites in 20 countries.
183 sites in 20 countries
United States85 sites
Abilene, TX
Abilene, Texas, 79606
Amarillo, TX
Amarillo, Texas, 79106
Amarillo, TX
Amarillo, Texas, 79109
Arlington, TX
Arlington, Texas, 76012
Asheville, NC
Asheville, North Carolina, 28803
Austin, TX
Austin, Texas, 78705
Bakersfield, CA
Bakersfield, California, 93309
Beaufort, SC
Beaufort, South Carolina, 29902
Beaumont, TX
Beaumont, Texas, 77707
Bellaire, TX
Bellaire, Texas, 77401
Bethlehem, PA
Bethlehem, Pennsylvania, 18017
Bloomfield, NJ
Bloomfield, New Jersey, 07003
Cherry Hill, NJ
Cherry Hill, New Jersey, 08034
Cleveland, Ohio
Cleveland, Ohio, 44122
Cleveland, OH
Cleveland, Ohio, 44130
Colorado Springs, CO
Colorado Springs, Colorado, 80909
Dallas, TX
Dallas, Texas, 75231
Danbury, CT
Danbury, Connecticut, 06810
Deerfield Beach, FL
Deerfield Beach, Florida, 33064
Denver, Colorado
Denver, Colorado, 80210
Edmond, OK
Edmond, Oklahoma, 73013
Erie, PA
Erie, Pennsylvania, 16507
Fayetteville, Arkansas
Fayetteville, Arkansas, 72703
Florence, SC
Florence, South Carolina, 29501
Fort Lauderdale, FL
Fort Lauderdale, Florida, 33308
Fort Myers,FL
Fort Myers, Florida, 33912
Fort Worth, TX
Fort Worth, Texas, 76104
Gainesville, FL
Gainesville, Florida, 32607
Germantown, TN
Germantown, Tennessee, 38138
Glendale, CA
Glendale, California, 91204
Grand Rapids, Michigan
Grand Rapids, Michigan, 49546
Hagerstown, MD
Hagerstown, Maryland, 21740
Hickory, NC
Hickory, North Carolina, 28602
Hixson, Tennessee
Hixson, Tennessee, 37343
Johnson City, Tennessee
Johnson City, Tennessee, 37604
Katy, TX
Katy, Texas, 77494
Knoxville, TN
Knoxville, Tennessee, 37922
Ladson, SC
Ladson, South Carolina, 29456
Lemont, IL
Lemont, Illinois, 60439
Lenexa, Kansas
Lenexa, Kansas, 66215
Liverpool, NY
Liverpool, New York, 13088
Lynchburg, VA
Lynchburg, Virginia, 24502
Madison, MS
Madison, Mississippi, 39110
Manchester, CT
Manchester, Connecticut, 06042
Minneapolis, MN
Minneapolis, Minnesota, 55435
Modesto, CA
Modesto, California, 95356
Mountain View, CA
Mountain View, California, 94040
Nashville, TN
Nashville, Tennessee, 37203
Oceanside, NY
Oceanside, New York, 11572
Orlando, Florida
Orlando, Florida, 32806
Plano, TX
Plano, Texas, 75075
Plantation, FL
Plantation, Florida, 33324
Portland, Maine
Portland, Maine, 04101
Portland, OR
Portland, Oregon, 97221
Redlands, CA
Redlands, California, 92374
Richmond, Virginia
Richmond, Virginia, 23235
Rochester, NY
Rochester, New York, 14620
Round Rock, TX
Round Rock, Texas, 78681
Sacramento, CA
Sacramento, California, 95825
Sacramento, CA
Sacramento, California, 95841
Salt Lake City, Utah
Salt Lake City, Utah, 84107
San Antonio, TX
San Antonio, Texas, 78240
Santa Ana
Santa Ana, California, 92705
Sarasota, FL
Sarasota, Florida, 34232
Schertz, Texas
Schertz, Texas, 78154
Scottsdale
Scottsdale, Arizona, 85255
Spokane, WA
Spokane, Washington, 99204
Springdale, Arkansas
Springdale, Arkansas, 72764
Springfield, Illinois
Springfield, Illinois, 62702
Springfield,MA
Springfield, Massachusetts, 01107
Springfield, Oregon
Springfield, Oregon, 97477
Saint Petersburg, FL
St. Petersburg, Florida, 33711
Tallahassee, FL
Tallahassee, Florida, 32308
Tampa, FL
Tampa, Florida, 33609-4614
Tampa, FL
Tampa, Florida, 33617
The Woodlands, TX
The Woodlands, Texas, 77384
Wake Forest, MC
Wake Forest, North Carolina, 27587
Waterford,CT
Waterford, Connecticut, 06385
West Columbia, SC
West Columbia, South Carolina, 29169
West Des Moines, IA
West Des Moines, Iowa, 50266
Wichita, Kansas
Wichita, Kansas, 67214
Willow Park, TX
Willow Park, Texas, 76087
Winston Salem, NC
Winston-Salem, North Carolina, 27103
Winter Haven, FL
Winter Haven, Florida, 33880
Youngstown, Ohio
Youngstown, Ohio, 44505
Argentina9 sites
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, C1116ABA
Buenos Aires, Argentina
CABA, Buenos Aires, 1015
Buenos Aires, Argentina
CABA, Buenos Aires, 1120
Buenos Aires, Argentina
CABA, Buenos Aires, C1033AAW
Buenos Aires, Argentina
CABA, 1023
Cordoba, Argentina
Córdoba, Córdoba Province, 5000
Ciudad de Cordoba, Argentina
Córdoba, X5000AAJ
Santa Fe, Argentina
Rosario, Santa Fe Province, S2000DSK
Santa Fe, Argentina
Rosario, Sante Fe, 2000
Poland9 sites
Bialystok, Poland
Bialystok, 15-866
Bydgoszcz, Poland
Bydgoszcz, 85-309
Bydgoszcz, Poland
Bydgoszcz, 85-631
Gdansk, Poland
Gdansk, Gdansk, 80-809
Gdansk, Poland
Gdansk, 80-809
Katowice, Poland
Katowice, 40-594
Krakow, Poland
Krakow, 31-501
Olsztyn, Poland
Olsztyn, 10-424
Tarnowskie Gory, Poland
Tarnowskie Góry, 42-600
France8 sites
Creteil, France
Créteil, 94010
Cedex, France
Dijon, Cedex, 21079
Lyon, France
Lyon, 69004
Marseille, France
Marseille, 13008
Paris, France
Paris, 75006
Paris, France
Paris, 75015
Paris, France
Paris, 75019
Saint Cyr sur Loire, France
Saint-Cyr-sur-Loire, 37540
Hungary8 sites
Budapest, Hungary
Budapest, H-1062
Budapest, Hungary
Budapest, H-1085
Budapest, Hungary
Budapest, H-1106
Budapest, Hungry
Budapest, H-1133
Debrecen, Hungary
Debrecen, H-4032
Pecs, Hungary
Pécs, H-7621
Szeged, Hungary
Szeged, H-6720
Zalaegerszeg, Hungary
Zalaegerszeg, 8900
Italy8 sites
Bologna, Italy
Bologna, 40138
Firenze, Italy
Florence, 50139
Milano, Italy
Milan, 20122
Milano, Italy
Milan, 20132
Milano, Italy
Milan, 20157
Roma, Italy
Roma, 00168
Rome, Italy
Rome, 81.00133
Udine, Italy
Udine, 33100
Spain8 sites
Barcelona, Spain
Barcelona, 08021
Barcelona, Spain
Barcelona, 08022
Barcelona, Spain
Barcelona, 08035
Barcelona, Spain
Barcelona, 08195
Valencia, Spain
Burjassot, Valencia, 46100
Santiago de Compostela, Spain
Santiago de Compostela, 15706
Sevilla, Spain
Seville, 41009
Zaragoza, Spain
Zaragoza, 50009
United Kingdom7 sites
Bradford, United Kingdom
Bradford, BD9 6RJ
Bristol, UK
Bristol, BS1 2LX
Liverpool, United Kingdom
Liverpool, L7 8YA
London, UK
London, Middlesex, NW10 7NS
Sunderland, United Kingdom
Sunderland, SR2 9HP
Wolverhamptom, United Kingdom
Wolverhampton, WV10 0QP
York, United Kingdom
York, UnitedKingdom, YO10 4DZ
Israel6 sites
Beer Yakov, Israel
Be’er Ya‘aqov, 70300
Haifa, Israel
Haifa, 3436212
Jerusalem, Israel
Jerusalem, 9112001
Petah Tikva, Israel
Petah Tikva, 49100
Rehovot, Israel
Rehovot, 76100
Tel Aviv, Israel
Tel Aviv, 6423906
Australia5 sites
Albury, Australia
Albury, 2640
Parramatta, Australia
Parramatta, 2150
Sydney Retina Clinic
Sydney, New South Wales, 2000
Sydney, Australia
Sydney, New South Wales, 2135
Sydney, Australia
Sydney, 2000
Colombia5 sites
Barranquilla, Colombia
Barranquilla, Atlántico, 80002
Bogota, Columbia
Bogotá, Columbia, 110231
Cali, Colombia
Cali, Valle del Cauca Department, 760042
Medellin, Colombia
Medellín, Antioquia, 50021
Medellin, Colombia
Medellín, 50016
Austria4 sites
Graz, Austria
Graz, 8036
Innsbruck, Austria
Innsbruck, 6020
Vienna, Austria
Vienna, 1090
Vienna, Austria
Vienna, 1140
Czechia4 sites
Mlada Boleslav, Czechia
Mladá Boleslav, 293 01
Nachod, Czechia
Náchod, 547 01
Prague, Czechia
Prague, 1150/50
Prague, Czechia
Prague
Germany4 sites
Frankfurt, Germany
Frankfurt, 60590
Hanover, Germany
Hanover, 30625
Munchen, Germany
München, 80336
Munster, Germany
Münster, 48145
Portugal3 sites
Coimbra, Portugal
Coimbra, 3000-548
Coimbra, Portugal
Coimbra, 3030-163
Porto, Portugal
Porto, 4200-319
Slovakia3 sites
Trebisov, Slovakia
Trebišov, 075 01
Trencin, Slovakia
Trenčín, 911 01
Zilina, Slovakia
Žilina, 012 07
Turkey (Türkiye)3 sites
Ankara, Turkey
Ankara, Turkey, 06230
Ankara, Turkey
Ankara, Turkey, 06490
Balcova, Turkey
Balçova, Turkey, 35330
About this study
Official title: A Randomized, Double-Masked, Multi-Center, 3-Arm Pivotal Phase 2/3 Study to Evaluate The Efficacy and Safety of Intravitreal EYE103 Compared With Intravitreal Ranibizumab (0.5mg) in Participants With Diabetic Macular Edema
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig (EYE103) in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval algorithm.
Approximately 960 participants will be entered in the study.
Read the detailed description
EYE-RES-102 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of remigromig in comparison with the active control, ranibizumab, in patients with diabetic macular edema (DME)
Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose remigromig, high dose remigromig, or 0.5 mg ranibizumab, administered via intravitreal injection. In the first year, all 3 treatment groups will be treated every 4 weeks with either remigromig or ranibizumab. Beginning at Year 2, the frequency of treatment for participants will shift based on a personalized treatment interval (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA), examination by slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT). Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- Ranibizumab, Remigromig
- Keywords
- Diabetic Macular Edema, DME
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanibizumabDrug
Also called Lucentis
Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema
RemigromigDrug
Also called EYE103, Restoret
Remigromig is a humanized antibody formulated for intravitreal administration
| Study group | Role | What they receive |
|---|---|---|
| Remigromig Low Dose Treatment Arm | Experimental | Remigromig Low Dose Treatment Arm Receives: Drug: Remigromig |
| Remigromig High Dose Treatment Arm | Experimental | Remigromig High Dose Treatment Arm Receives: Drug: Remigromig |
| Ranibizumab Treatment Arm | Active comparator | Ranibizumab Treatment Arm 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) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart
The change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.
Measured: Baseline and Week 52
Secondary outcomes (11)
Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52
The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented.
Measured: Baseline and Week 52
Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52
The Superiority Hypothesis: change from baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.
Measured: Baseline and Week 52
Time to Absence of Diabetic Macular Edema (DME)
The time to absence of Diabetic Macular Edema (DME) defined as Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) of <300 μm will be presented.
Measured: Up to approximately Week 104
Time to Gaining ≥15 ETDRS letters
The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented.
Measured: Up to approximately Week 52
Proportion of Participants with Resolution of Macular Leakage on FA at Week 24
The proportion of participants with resolution of macular leakage on fluorescein angiography (FA), defined as 0 to 1 mm^2, at Week 24 will be presented.
Measured: Up to approximately Week 24
Proportion of Participants Without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52
The proportion of participants without intraretinal and subretinal fluid at the foveal center on Optical Coherence Tomography (OCT) at Week 52 will be presented.
Measured: Up to approximately Week 52
Change from Baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52
The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented.
Measured: Baseline and Week 52
Proportion of Participants Achieving 20/40 or Better BCVA at Week 52
The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented.
Measured: Up to approximately Week 52
Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic AE will be reported.
Measured: Up to approximately 104 Weeks
Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE)
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an ocular and/or systemic serious adverse event (SAE) will be reported.
Measured: Up to approximately 104 Weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 104 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start7 Aug 2024
- Primary completion14 Jul 2026
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel enrollment into 1 of 3 arms
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyeBiotech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Charles Miller, MD PhD, Study director, EyeBiotech Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571045
- Sponsor's protocol ID
- EYE-RES-102
- Other IDs
- MK-3000-001
- Acronym
- BRUNELLO
- Status last verified
- Oct 2026
- First submitted
- 20 Aug 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No