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601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)

A Randomized, Double Masked, Multicenter, Phase II Study Assessing the Safety and Efficacy of 601 Versus Ranibizumab in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)

NCT04667910•Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

View on ClinicalTrials.gov

Summary

To evaluate the safety and efficacy of intravitreal recombinant humanized anti-VEGF monoclonal antibody in patients with visual impairment due to macular edema secondary to CRVO

Detailed Description

Following a 14-day maximum screening period, patients will be randomized and followed for approximately 52 weeks. Treatment visits will be scheduled in 4-week intervals. 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, an assessment of disease stability will be performed at each monthly visit and subjects will receive either an injection or not. Safety and efficacy outcomes will continue to be evaluated up to a period of 52 weeks unless the patient is withdrawn or discontinues the study.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Sign informed consent form and willing to be visited at the time specified in the trial
•Male or Female, at least 18 years of age
•The study eye must meet the following criteria
•1. Diagnosed with macular edema secondary to central retinal vein occlusion within 12 months
•2. BCVA score between 78 and 19 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/400)
•3. CRT ≥ 250μm
•4. No optometric media opacity and pupil abnormal
•BCVA score ≥ 34 letters in the fellow eye, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/200)

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 first 12-month study period (e.g. scarring, fibrosis or atrophy of the fovea, dense subfoveal hard exudates, significant hemorrhage obscuring the macular, vitreous hemorrhage, vitreomacular traction, retinal vascular occlusion other than CRVO, retinal detachment, macular hole, or age-related macular degeneration，choroidal neovascularization of any cause, diabetic retinopathy (except mild non-proliferative) and diabetic macular edema). Hemiretinal vein occlusion (HRVO) should be excluded
•iris, chamber angle neovascularization or retinal, optic disc neovascularization
•Previous use of intraocular or periocular steroids within 3 months prior to baseline, or previous use of dexamethasone intravitreal implant within 6 months prior to baseline
•Macular laser photocoagulation (focal/grid)，panretinal laser photocoagulation，vitrectomy，radial optic neurotomy arteriovenous sheathotomy，trabeculectomy or keratoplasty in the study eye at any time prior to baseline. Local laser photocoagulation, YAG laser treatment or any other ocular surgeries (e.g. cataract surgery ) in the study eye within 3 months prior to the baseline
•During the screening period, the BCVA is \>10 letters improved (the BCVA detected within 24 hours before the administration at day 0 compared with the BCVA at the screening)
•Aphakia (except IOL) or posterior capsular defect (except YAG posterior capsulotomy after intraocular lens implantation surgery)
•For Any Eye:
•Any eye has active ocular infections (e.g. blepharitis, conjunctivitis, keratitis, scleritis, uveitis, endophthalmitis)
•Uncontrollable glaucoma (defined as intraocular pressure after antiglaucoma therapy\>= 25 mm Hg), or the cup/disk ratio \>0.8 in the study eye
+14 more criteria

Locations (1)

TianJing Medical University Eye Hospital

Tianjing, TianJing, China

Key Dates

Start Date

January 27, 2021

Primary Completion Date

November 16, 2022

Completion Date

November 16, 2022

Last Updated

June 27, 2025

Enrollment

ACTUAL participants

Conditions

Central Retinal Vein Occlusion

Interventions

601 1.25mg

DRUG

Ranibizuman 0.5 mg

DRUG

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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: June 27, 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.

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601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)

Inclusion Criteria

Exclusion Criteria

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