Status:
COMPLETED
601 Versus Ranibizumab in Patients With Central Retinal Vein Occlusion (CRVO)
Lead Sponsor:
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Conditions:
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 inject...
Eligibility Criteria
Inclusion
- 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
- Diagnosed with macular edema secondary to central retinal vein occlusion within 12 months
- BCVA score between 78 and 19 letters, inclusive, using ETDRS visual acuity testing charts (approximate Snellen equivalent of 20/32 to 20/400)
- CRT ≥ 250μm
- 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
- 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
- History of intravitreal use of anti-VEGF drugs (e.g. ranibizumab，bevacizumab，aflibercept, conbercept, etc.) in any eye within 3 months prior to baseline
- General
Key Trial Info
Start Date :
January 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 16 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04667910
Start Date
January 27 2021
End Date
November 16 2022
Last Update
June 27 2025
Active Locations (1)
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1
TianJing Medical University Eye Hospital
Tianjing, TianJing, China, 300384