A Randomized, Double Masked, Multicenter, Phase III Study Assessing the Efficacy and Safety of 601 Versus Ranibizumab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
To compare the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody (601) with Ranibizumab in patients with macular edema secondary to BRVO
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Sign informed consent form and willing to be followed up at the time specified in the trial
• Male or Female, at least 18 years of age
• The study eye must meet the following criteria：Diagnosed with macular edema secondary to Branch retinal vein occlusion (BRVO) or Hemi-retinal vein occlusion (HRVO) within 12 months; BCVA score ≤ 73 and ≥19 letters using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/40 to 20/400); CRT ≥ 250μm; No optometric media opacity and pupil abnormal
• BCVA score ≥ 34 ETDRS letters (approximate Snellen equivalent of 20/200) in the fellow eye, with no active RVO disease.
Locations
Other Locations
China
BeiJing Hospital
RECRUITING
Beijing
The Second XiangYa Hospital of Central South University
RECRUITING
Changsha
West China Hospital of Sichuan University
RECRUITING
Chengdu
The First Affiliated Hospital of JiNan University
RECRUITING
Guangzhou
ZheJiang Province People's Hospital
RECRUITING
Hangzhou
JiangSu Province Hospital
RECRUITING
Nanjing
ShangHai General Hospital
RECRUITING
Shanghai
TianJin Eye Hospital
RECRUITING
Tianjin
TianJin Medical University Eye Hospital
RECRUITING
Tianjin
HeNan Provincial Eye Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Gang Tong, Bachelor of Medicine
tonggang@3s-guojian.com
021-60790099
Time Frame
Start Date:2022-12-27
Estimated Completion Date:2025-12
Participants
Target number of participants:350
Treatments
Experimental: 601 1.25mg
loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
Active_comparator: ranibizumab 0.5mg
loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses