An Efficacy and Safety Trial of Intravitreal Injection of Conbercept Ophthalmic Injection in Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion
Overview
- Phase
- Phase 3
- Intervention
- Conbercept Ophthalmic Injection
- Conditions
- Macular Edema
- Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Enrollment
- 242
- Locations
- 27
- Primary Endpoint
- Best Corrected Visual Acuity
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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.
Detailed Description
The trial is divided into core and extension periods. 1. Core period (Day 0 - Month 5): Eligible subjects after the screening are assigned into the group to receive either intravitreal injection of Conbercept ophthalmic injection at a dose of 0.5 mg (treatment group) or a sham injection (control group) into their study eyes every month (Day 0 - Month 5). At month 6, primary endpoint are judged by investigators. 2. Extension period (Month 6 \~ 12): Subjects in treatment group are reviewed monthly, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). Subjects in control group receive a single intravitreal injection of 0.5 mg Conbercept ophthalmic injection in month 6, followed monthly review, if he/she meets the criteria for repeated administration, the subject receives 0.5 mg Conbercept injection into the study eye (Month 6 \~ 11). The final evaluation is performed at the end of Month 12.
Investigators
Eligibility Criteria
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:
- •Suffering from macular edema secondary to CRVO or HRVO that involves the fovea and has been first diagnosed within previous 12 months;
- •Best corrected visual acuity (BCVA) ≥24 and ≤73 letters (Snellen equivalent is 20 / 320-20 / 40);
- •Central retinal thickness (CRT) on OCT is ≥300 μm;
- •Without opacities in the refractive media and pupillary miosis that affects fundus examination.
- •Note: If both eyes of a subject meet the inclusion criteria, the target eye shall be determined by investigators from a medical point of view.
Exclusion Criteria
- •Patients who present with any the following ocular conditions:
- •Study eyes
- •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.;
Arms & Interventions
Conbercept
Conbercept
Intervention: Conbercept Ophthalmic Injection
Conbercept or sham
Conbercept or sham
Intervention: Conbercept Ophthalmic Injection
Conbercept or sham
Conbercept or sham
Intervention: sham injection
Outcomes
Primary Outcomes
Best Corrected Visual Acuity
Time Frame: month 6
To compare mean changes in Best Corrected Visual Acuity (BCVA) from baseline between the Conbercept ophthalmic injection treatment group (treatment group) and the control group at month 6.
Secondary Outcomes
- Central Retinal Thickness(month 3, month6 and month 12)
- Number of participants with treatment-related the systemic and ocular safely as assessed(month 6 and month 12 or trail period)
- Number of subject who received laser rescue treatment(month 6 and month 12)
- Best Corrected Visual Acuity(month 3 and month 12)