A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss (NCT05520177) | Clinical Trial Compass
CompletedPhase 3
A Phase III Study for 601 Versus Ranibizumab in Patients With Vision Loss
China351 participantsStarted 2022-12-27
Plain-language 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
Who can participate
Age range18 Years
SexALL
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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 …