NCT06571045

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME

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
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 984 (actual)
• Sponsor: EyeBiotech Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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) Approximately 960 participants will be entered in the study. Participants will be randomized 1:1:1 to receive low dose EYE103, high dose EYE103, or 0.5 mg ranibizumab, administered via intravitreal injection. 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 (PTI) algorithm. Throughout the 2-year study, subjects will be evaluated every 4 weeks, including measurement of ETDRS BCVA, examination by slit-lamp biomicroscopy, fundoscopy, and SD-OCT. Among other parameters, SD-OCT will be used to measure central subfield thickness (CST) in microns.

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-08-07
• Primary completion: 2026-09-01
• Completion: 2027-12-31
• First posted: 2024-08-26
• Last updated: 2025-08-12

Locations

183 sites across 20 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

Regulatory

• FDA-regulated drug study