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NCT06571045 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Efficacy and Safety 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
- 984
- Enrollment target
- 20
- Study locations
NCT06571045: Active Phase 2 study of Diabetic Macular Edema (DME), sponsored by EyeBiotech.
NCT06571045 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 984 participants, above the 239-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (312% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06571045, 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
- 984 participants
- Enrollment target
- 20
- Study locations
Study Summary
EYE-RES-102 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
- Glendale, CA - Glendale
- Modesto, CA - Modesto
- Mountain View, CA - Mountain View
- Redlands, CA - Redlands
- Sacramento, CA - Sacramento
- Sacramento, CA - Sacramento
- Santa Ana - Santa Ana
Florida
- Deerfield Beach, FL - Deerfield Beach
- Fort Lauderdale, FL - Fort Lauderdale
- Fort Myers,FL - Fort Myers
- Gainesville, FL - Gainesville
Connecticut
- Danbury, CT - Danbury
- Manchester, CT - Manchester
- Waterford,CT - Waterford
Arkansas
- Fayetteville, Arkansas - Fayetteville
- Springdale, Arkansas - Springdale
Colorado
- Colorado Springs, CO - Colorado Springs
- Denver, Colorado - Denver
Arizona
- Scottsdale - Scottsdale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 984 participants |
| Start Date | 2024-08-07 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 2 |
What the registry record for NCT06571045 still lists
NCT06571045 is an interventional study that assigns participants to a tested intervention. The registered 984 participants enrollment target is mid-sized for trials with a published cap, above the 239-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (312% 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.
NCT06571045 names 20 study sites across 6 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06571045 about?
NCT06571045 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME". EYE-RES-102 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 eith...
What is the current status of trial NCT06571045?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 984 participants. The study started on 2024-08-07. Estimated completion is 2027-12-31.
What conditions does trial NCT06571045 study?
This clinical trial studies the following conditions: Diabetic Macular Edema (DME).
What interventions are being tested in trial NCT06571045?
The interventions under investigation include: EYE103 (DRUG), Ranibizumab (DRUG).
Who is sponsoring clinical trial NCT06571045?
This trial is sponsored by EyeBiotech, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06571045 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 NCT06571045's enrollment target sits among peer trials
984 2nd of 8 the highest 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
-
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A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
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A Study of Avoralstat In Participants With Diabetic Macular Edema
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