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Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema - Trial NCT05885503

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.

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NCT05885503
Phase 3
Not yet recruiting
biological
Trial Details
ClinicalTrials.gov • NCT05885503
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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

Study Focus

Diabetic Macular Edema

RC-28E

Interventional

biological

Sponsor & Location

RemeGen Co., Ltd.

Timeline & Enrollment

Phase 3

Jun 01, 2023

Jun 01, 2026

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 retinopathy
Other specified diabetes mellitus with ophthalmic complications
Unspecified diabetes mellitus with ophthalmic complications
Diabetic cataract
Type 2 diabetes mellitus with ophthalmic complications

Data Source

ClinicalTrials.gov

NCT05885503

Non-Device Trial