A Randomized, Double-masked, Multi-center, 3-Arm Pivotal Phase 2/3 Study to Evaluate the Efficacy and Safety of Intravitreal EYE103 Compared with Intravitreal ranibizumab (0.5mg) in Participants with Diabetic Macular Edema

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-520809-12-00

Acronym

EYE-RES-103

Enrollment

465

Registered

2025-06-24

Start date

2025-10-16

Completion date

Unknown

Last updated

2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Brief summary

The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).

Interventions

DRUGEYE103

DRUGFluorescein Alcon® 10 % Injektionslösung

DRUGLucentis 10 mg/ml solution for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).	—

Countries

Austria, Croatia, Czechia, France, Germany, Hungary, Italy, Latvia, Poland, Portugal, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026