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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 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.

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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.

Conditions Studied

Diabetic Macular Edema (DME)

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

FieldValue
Enrollment Target 1,054 participants
Start Date 2025-04-16
Est. Completion 2028-03-30
Phase Phase 2

Sponsor

EyeBiotech

7 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06957080

The ClinicalTrials.gov registry entry for NCT06957080 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 1,054 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 230-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (358% higher). The listed sponsor is EyeBiotech, which has 7 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 5 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.