NCT05885503
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
RemeGen Co., Ltd.·Phase 3·ClinicalTrials.gov·biologicalNot yet recruiting
View on ClinicalTrials.gov →Study focus
- Disease/Condition
- Diabetic Macular Edema
- Drug/Device/Intervention
- RC-28E
- Study type
- Interventional
- Intervention type
- biological
Sponsor & location
- Primary sponsor
- RemeGen Co., Ltd.
Timeline & enrollment
- Phase
- Phase 3
- Start date
- Jun 01, 2023
- End date
- Jun 01, 2026
- Enrollment
- 316 participants
Primary outcome
Change from baseline in BCVA at Week 52
Summary
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with
 Aflibercept in subjects with diabetic macular edema.
ICD-10 classifications
Diabetic retinopathyOther specified diabetes mellitus with ophthalmic complicationsUnspecified diabetes mellitus with ophthalmic complicationsDiabetic cataractType 2 diabetes mellitus with ophthalmic complications
Data source
- Registry
- ClinicalTrials.gov
- Trial ID
- NCT05885503
- Type
- Non-Device Trial
About this record
Access comprehensive clinical trial information for NCT05885503 through Pure Global AI's free database. This Phase 3 trial is sponsored by RemeGen Co., Ltd. and is currently Not yet recruiting. The study focuses on Diabetic Macular Edema. Target enrollment is 316 participants.
This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.