> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-of-2-doses-of-eye103-compared-with-ranibizumab-0-5-4942bc96-906b-4198-80f5-17330d8b6330 > Record changed: 2026-10-13 # A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME NCT06957080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Participants 1,054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Lead sponsor EyeBiotech Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Start date 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) Number of sites 164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Title and summary **Summary** EYE-RES-103 is a randomized, double masked pivotal study to evaluate the efficacy and safety of 2 dose levels of 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 EYE103 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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Acronym** BAROLO Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Short title** A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Dates **Completion date** 2028-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **First posted** 2025-05-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Registry last updated** 2026-08-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Primary completion date** 2027-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Start date** 2025-04-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Size and sites **Actual participants** 1,054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Participants** 1,054 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Protocol amendments** 4 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Number of sites** 164 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Lead sponsor** EyeBiotech Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Identifiers **Registry ID** NCT06957080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **ClinicalTrials.gov ID** NCT06957080 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Outcomes ### Primary outcomes 1. Change from baseline in Best-Corrected Visual Acuity (BCVA) measured using the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart Timeframe: Baseline and Week 52 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. ### Secondary outcomes 1. Change from Baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 Timeframe: Baseline and Week 52 The change from baseline in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) at Week 52 will be presented. 2. Superiority Hypothesis: Change from Baseline in ETDRS BCVA at Week 52 Timeframe: Baseline and 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. 3. Time to Absence of Diabetic Macular Edema (DME) Timeframe: Up to approximately Week 52 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. 4. Time to Gaining ≥15 ETDRS Letters Timeframe: Up to approximately Week 52 The time to gaining ≥15 letters on the standardized Early Treatment of Diabetic Retinopathy Study (ETDRS) chart will be presented. 5. Proportion of Participants with Resolution of Macular Leakage on Fluorescein Angiography (FA) at Week 24 Timeframe: Up to approximately 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. 6. Proportion of Participants without Intraretinal and Subretinal Fluid at the Foveal Center on OCT at Week 52 Timeframe: Up to approximately 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. 7. Change from Baseline in Focal Area Zone (FAZ) area on Fluorescein Angiography (FA) at Week 52 Timeframe: Baseline and Week 52 The change from baseline in Focal Area Zone (FAZ) area on fluorescein angiography (FA) at Week 52 will be presented. 8. Proportion of Participants Achieving 20/40 or Better BCVA at Week 52 Timeframe: Up to approximately Week 52 The proportion of participants who achieve 20/40 or better Best-Corrected Visual Acuity (BCVA) at Week 52 will be presented. 9. Number of Participants Who Experience an Ocular and/or Systemic Adverse Event (AE) Timeframe: Up to approximately 104 Weeks 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. 10. Number of Participants Who Experience an Ocular and/or Systemic Serious Adverse Event (SAE) Timeframe: Up to approximately 104 Weeks 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. 11. Number of Participants Who Discontinue Study Treatment Due to an AE Timeframe: Up to approximately 104 Weeks 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. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - 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). ### Exclusion criteria - 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 - Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept \[2 mg\], pegaptanib sodium) in the study eye within 90 days of the Screening visit Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Sites - Gilbert, ArizonaGilbert, United States - Phoenix, ArizonaPhoenix, United States - Scottsdale, AZScottsdale, United States - Fayetteville, ARFayetteville, United States - Bakersfield, CABakersfield, United States - Encino, CaliforniaEncino, United States - Modesto, CAModesto, United States - Mountain View, CAMountain View, United States - Redlands, CARedlands, United States - Sacramento, CASacramento, United States - Sacramento, CASacramento, United States - Santa Ana, CASanta Ana, United States - Santa AnaSanta Ana, United States - Colorado Springs, COColorado Springs, United States - Denver, CODenver, United States - Durango, CODurango, United States - Danbury, CTDanbury, United States - Manchester, CTManchester, United States - Waterford, CTWaterford, United States - Waterford,CTWaterford, United States - Deerfield Beach, FLDeerfield Beach, United States - Fort Lauderdale, FLFort Lauderdale, United States - Fort Myers, FLFort Myers, United States - Gainesville, FLGainesville, United States - Orlando, FLOrlando, United States And 139 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## References ### Other registry identifiers (4) - MK-3000-002 - 2025 - 2025-520809-12-00 - jRCT2071250032 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06957080) ## Related records ### Drugs (1) - [Ranibizumab](https://trialight.com/data/asset/ranibizumab-2ca53f2a-3d69-417e-a84c-3f9e436c1913.md) ### Lead sponsors (1) - [EyeBiotech Ltd.](https://trialight.com/data/company/eyebiotech-ltd-f9e7412c-e280-452d-8432-26e5fabee9a4.md) ### Conditions (1) - [Diabetic macular edema](https://trialight.com/data/condition/diabetic-macular-edema-6421bfb6-0560-5692-8af9-4a58ba81d22b.md) Primary condition ### Targets (1) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. 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