Loading clinical trials...

COMPLETEDPHASE3

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

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)

NCT05520177•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

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

Detailed Description

After a up to 14-day screening period, patients will be randomized allocated in 2 groups at 1:1 ratio and followed up for 52 weeks. Followed-up visits will be scheduled at a 4-week interval. After 6 initial monthly injections of 601 or ranibizumab (loading phase), subjects will enter an individualized flexible treatment (IFT) phase (week 24 to week 48). During the IFT phase, subjects will receive either the injections or not based on the assessment of disease stability at each visit. Efficacy and safety outcomes will be evaluated up to a period of 52 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•For Study Eye: Concomitant conditions or ocular disorders in the study eye at screening or baseline which could, in the opinion of the investigator, prevent response to study treatment or may confound interpretation of study results, compromise visual acuity or require medical or surgical intervention during the 52-week study period
•For Study Eye: iris, chamber angle neovascularization or retinal, optic disc neovascularization
•For Study Eye: Previous use of intraocular or periocular steroids within 3 months prior to baseline, or dexamethasone intravitreal implant within 6 months prior to baseline
•For Study Eye: Macular laser photocoagulation (focal/grid)，panretinal laser photocoagulation，vitrectomy，trabeculectomy or keratoplasty in the study eye at any time prior to baseline. YAG laser treatment or any other intraocular surgeries (e.g. cataract surgery) in the study eye within 3 months prior to the baseline
•For Study Eye: During the screening period, the BCVA is \>10 letters improved
•For Study Eye: Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery)
•For Any Eye: Active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis) in any eye
•For Any Eye: Uncontrolled glaucoma (defined as intraocular pressure after antiglaucoma therapy ≥ 25mmHg) in any eye, or the cup/disk ratio \>0.8 in the study eye
•For Any Eye: History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab，bevacizumab，aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline
•History of allergy to fluorescein sodium and allergies to protein products for treatment or diagnosis
+12 more criteria

Locations (10)

BeiJing Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of JiNan University

Guangzhou, Guangdong, China

HeNan Provincial Eye Hospital

Zhengzhou, Henan, China

The Second XiangYa Hospital of Central South University

Changsha, Hunan, China

JiangSu Province Hospital

Nanjing, Jiangsu, China

ShangHai General Hospital

Shanghai, Shanghai Municipality, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

TianJin Eye Hospital

Tianjin, Tianjin Municipality, China

TianJin Medical University Eye Hospital

Tianjin, Tianjin Municipality, China

ZheJiang Province People's Hospital

Hangzhou, Zhejiang, China

Key Dates

Start Date

December 27, 2022

Primary Completion Date

September 23, 2024

Completion Date

September 23, 2024

Last Updated

December 18, 2025

Enrollment

351

ACTUAL participants

Conditions

Branch Retinal Vein Occlusion

Interventions

601 1.25mg

DRUG

ranibizumab 0.5mg

DRUG

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

NCT05476926

Neovascular Age-related Macular DegenerationDiabetic Macular Edema+4 more

View study

COMPLETEDPHASE4

Ocular Safety and Usability Study for FYB203 PFS

NCT06708637

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Real-World Study to Gain Clinical Insights Into Roche Ophthalmology Products

Ocular Safety and Usability Study for FYB203 PFS

Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study

Phase 1 Open-label Study to Evaluate Efficacy and Tolerability of TLC399 in Patients With Macular Edema Due to RVO

Study to Show a Superior Benefit in Terms of Reduction of Ranibizumab Injections in Patients Receiving Ranibizumab Plus Laser Photocoagulation Combination Therapy Without Loss of Efficacy and Safety

Retrospective Study of the Effectiveness and Safety of Niacin and Steroid Eye Drops for Retinal Vein Occlusions