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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
NCT06571045 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06571045
The ClinicalTrials.gov registry entry for NCT06571045 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 984 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is EyeBiotech, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06571045 reports 20 study locations spanning 6 distinct geographic areas — top geographies include California, Florida, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06571045?
The interventions under investigation include: EYE103 (DRUG), Ranibizumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06571045?
This trial is sponsored by EyeBiotech, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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