A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss

Conditions

• Branch Retinal Vein Occlusion

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 601 1.25mg — DRUG
  loading phase (6 months): 601 1.25mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses
• ranibizumab 0.5mg — DRUG
  loading phase (6 months): ranibizumab 0.5mg/eye/time, Intravitreal injection, administered once every 4 weeks for 6 consecutive doses

Study Details

To compare the efficacy and safety of recombinant humanized anti-VEGF monoclonal antibody (601) with Ranibizumab in patients with macular edema secondary to BRVO

Key Dates

First listed

Aug 29, 2022

Start date

Dec 27, 2022

Status verified

Jan 2023

Primary completion

Sep 23, 2024

Completion

Sep 23, 2024

Study Design

Enrollment

351 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

best-corrected visual acuity (BCVA) [ Time Frame: From Baseline to Week 24 ]