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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 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.

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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.

Conditions Studied

Diabetic Macular Edema (DME)

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

FieldValue
Enrollment Target 984 participants
Start Date 2024-08-07
Est. Completion 2027-12-31
Phase Phase 2

Sponsor

EyeBiotech

7 total trials

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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, categorized as Phase 2. The registered enrollment target is 984 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 239-participant average among 8 other Diabetic Macular Edema (DME) trials with a reported enrollment target (312% 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.

NCT06571045 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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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.