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

NCT05885503 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 316

Last updated 2023-09-05

No results posted yet for this study

Summary

The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.

Conditions

Interventions

BIOLOGICAL

RC-28E

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.

BIOLOGICAL

Aflibercept

Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.

Sponsors & Collaborators

  • RemeGen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Youxin Chen · Peking Union Medical College Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-08
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

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 NCT05885503 on ClinicalTrials.gov