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NCT06957080 · ClinicalTrials.gov registry record · Phase 2
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
A Phase 2 study of Diabetic Macular Edema (DME), sponsored by EyeBiotech.
- Active
- Registry status
- Phase 2
- Development phase
- 1,054
- Enrollment target
- 20
- Study locations
NCT06957080: Active Phase 2 study of Diabetic Macular Edema (DME), sponsored by EyeBiotech.
NCT06957080 is a Phase 2 study of Diabetic Macular Edema (DME) that is active but no longer recruiting, run by EyeBiotech. The registered enrollment target is 1,054 participants, above the 230-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (358% higher). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06957080, a Phase 2 study of Diabetic Macular Edema (DME), is active but no longer recruiting, sponsored by EyeBiotech.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,054 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG EYE103
- DRUG Ranibizumab
Study Locations (20)
California
- Bakersfield, CA - Bakersfield
- Encino, California - Encino
- Modesto, CA - Modesto
- Mountain View, CA - Mountain View
- Redlands, CA - Redlands
- Sacramento, CA - Sacramento
- Sacramento, CA - Sacramento
- Santa Ana, CA - Santa Ana
- Santa Ana - Santa Ana
Connecticut
- Danbury, CT - Danbury
- Manchester, CT - Manchester
- Waterford, CT - Waterford
- Waterford,CT - Waterford
Arizona
- Gilbert, Arizona - Gilbert
- Phoenix, Arizona - Phoenix
- Scottsdale, AZ - Scottsdale
Colorado
- Colorado Springs, CO - Colorado Springs
- Denver, CO - Denver
- Durango, CO - Durango
Arkansas
- Fayetteville, AR - Fayetteville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,054 participants |
| Start Date | 2025-04-16 |
| Est. Completion | 2028-03-30 |
| Phase | Phase 2 |
What the registry record for NCT06957080 still lists
NCT06957080 is an interventional study that assigns participants to a tested intervention. Its 1,054 participants enrollment target places it among the larger protocols in the corpus, above the 230-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (358% higher).
The record links to 1 condition, with Diabetic Macular Edema (DME) appearing as the primary indexed condition, and to 2 interventions - of which EYE103 is the first listed.
NCT06957080 names 20 study sites across 5 states, led by California, Connecticut, Arizona.
Frequently Asked Questions
What is clinical trial NCT06957080 about?
NCT06957080 is a clinical study titled "A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME". 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 eit...
What is the current status of trial NCT06957080?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,054 participants. The study started on 2025-04-16. Estimated completion is 2028-03-30.
What conditions does trial NCT06957080 study?
This clinical trial studies the following conditions: Diabetic Macular Edema (DME).
What interventions are being tested in trial NCT06957080?
The interventions under investigation include: EYE103 (DRUG), Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT06957080?
This trial is sponsored by EyeBiotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06957080 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema (DME)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06957080's enrollment target sits among peer trials
1,054 1st of 8 higher than 8 of 8 other Diabetic Macular Edema (DME) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema (DME) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
ACTIVE NOT RECRUITING · Phase 2
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A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
ACTIVE NOT RECRUITING · Phase 2
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CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
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