Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion (NCT03223714) | Clinical Trial Compass
CompletedPhase 3
Conbercept Ophthalmic Injection for Patients of Central Retinal Vein Occlusion
China242 participantsStarted 2016-05-24
Plain-language summary
This study evaluates the efficacy and safety of Conbercept ophthalmic injection. This is a multi-center, randomized, double-masked, placebo-controlled phase III clinical study. 237 patients with central retinal vein occlusion(CRVO) are expected to be enrolled in the study and randomly assigned into the Conbercept ophthalmic injection treatment group or the control group at a ratio of 2:1.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Patients have signed informed consent and agreed to be followed up as per the trial protocol;
✓. Aged ≥ 18 years, male or female;
✓. Target eyes must meet all of following requirements:
✓. Without opacities in the refractive media and pupillary miosis that affects fundus examination.
Exclusion criteria
✕. Active retinal or iris neovascularization;
✕. Epiretinal membrane or vitreomacular traction that investigators consider likely to affect central vision;
✕. Other ocular diseases or conditions that may affect the recovery of the macula functions based on the opinion of investigators, such as foveal atrophy, foveal hemorrhage, foveal hard exudates, or dense submacular hard exudates, etc.;
✕. History of retinal detachment;
✕. Suffering from non-RVO diseases that may result in macular edema, visual acuity loss or retinal neovascularization during the study period based on the opinion of investigators, such as wet AMD, diabetic retinopathy, uveitis or other ocular inflammatory diseases, neovascular glaucoma, and cystoid macular edema, etc.;
✕. Patients with cataract whose eye is likely to require cataract surgery within the next 12 months;
✕. Have received intraocular injection of corticosteroid within previous 3 months, received subconjunctiva injection of corticosteroid within previous 6 months, or received ocular corticosteroid therapy within previous 1 month;
✕. Have undergone any of the following ocular surgeries: scleral buckling surgery, PDT, vitrectomy, radial optic neurotomy or sheathotomy, glaucoma filtration surgery, parafoveal photocoagulation, pan-retinal photocoagulation, and macular translocation surgery, etc.;