A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

NCT06957080
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Phase
Phase 2/Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,054
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Lead sponsor
EyeBiotech Ltd.
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Start date
2025-04-16
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Number of sites
164
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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.
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Acronym
BAROLO
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Short title
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
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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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2/Phase 3
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Study type
Interventional
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Completion date
2028-03-30
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First posted
2025-05-04
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Registry last updated
2026-08-20
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Primary completion date
2027-03-01
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Start date
2025-04-16
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Actual participants
1,054
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Participants
1,054
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Participant count basis
Actual
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Protocol amendments
4
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Randomisation ratio
1:1:1
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Number of sites
164
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
EyeBiotech Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06957080
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ClinicalTrials.gov ID
NCT06957080
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  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.

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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).

  • 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
clinicaltrials.gov

  • 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
clinicaltrials.gov

  • MK-3000-002
  • 2025
  • 2025-520809-12-00
  • jRCT2071250032
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (1)