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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 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 984

Last updated 2025-08-12

No results posted yet for this 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

  • Diabetic Macular Edema (DME)

Interventions

DRUG

Ranibizumab

Ranibizumab is a commercially available anti-VEGF treatment formulated for intravitreal administration for use in patients with diabetic macular edema

DRUG

EYE103

EYE103 is a humanized antibody formulated for intravitreal administration

Sponsors & Collaborators

  • EyeBiotech Ltd.

    lead INDUSTRY

Principal Investigators

  • Charles Miller, MD PhD · EyeBiotech Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-07
Primary Completion
2026-09-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Austria
  • Colombia
  • Croatia
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Latvia
  • Poland
  • Portugal
  • Puerto Rico
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06571045 on ClinicalTrials.gov