A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Documented diagnosed with type I or type II diabetes mellitus.
• Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
• Ability and willingness to undertake all scheduled visits and assessments.
• The study eye must meet the following requirements:
‣ macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
⁃ decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
Locations
Other Locations
China
Peking Union Medical College Hospital
RECRUITING
Beijing
Contact Information
Primary
Binghua Xiao
xiaosir522@163.com
86-010-58076833
Time Frame
Start Date: 2023-06-08
Estimated Completion Date: 2026-06
Participants
Target number of participants: 316
Treatments
Experimental: RC-28E
RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48.
Active_comparator: Aflibercept
Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48.
Related Therapeutic Areas
Sponsors
Leads: RemeGen Co., Ltd.