Multi-center, Randomized, Double-masked, Placebo-controlled Phase III Clinical Study of Conbercept Ophthalmic Injection for Patients With BRVO.

Chengdu Kanghong Biotech Co., Ltd.31 sites in 1 country255 target enrollmentApril 13, 2016

ConditionsBranch Retinal Vein Occlusion Macular Edema

InterventionsConbercept ophthalmic injection sham/Conbercept ophthalmic injection

DrugsConbercept ophthalmic injection

Overview

Phase: Phase 3
Intervention: Conbercept ophthalmic injection
Conditions: Branch Retinal Vein Occlusion
Sponsor: Chengdu Kanghong Biotech Co., Ltd.
Enrollment: 255
Locations: 31
Primary Endpoint: Best Corrected Visual Acuity
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to verify the efficacy and safety of intravitreal injection of conbercept in patients with macular edema (ME) caused by branch retinal vein occlusion (BRVO).

Registry

clinicaltrials.gov

Start Date

April 13, 2016

End Date

October 16, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients have signed informed consent form and agreed to be followed up as per the trial protocol;
•Aged ≥ 18 years, male or female;
•Study eyes must meet all of following requirements:
•Suffering from macular edema secondary to BRVO that involves the fovea and BRVO 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: The eye of interest is determined by the researcher from a medical point of view if both eyes of the patient meet the inclusion criteria. In principle, the eye with poor eyesight or thicker central retina should be selected as the eye of interest.

Exclusion Criteria

•Any subject who has any of the following ocular condition:
•Eye of interest
•Has active retina and/or iris neovascularization;
•Has macular epiretinal membranes or vitreous tractions which are considered to influence the central visual acuity by the researcher;
•Has other diseases which are considered to influence the macular functional recovery by the researcher, e.g., foveal atrophy, subfoveal hemorrhage, macular hard exudates or dense submacular hard exudates;
•Has a history of any type of retinal detachment;
•Has non-RVO ocular diseases which are considered to possibly cause macular edema, declined visual acuity or retinal neovascularization during the study period by the researcher, e.g., wet AMD, diabetic retinopathy, uveitis/other intraocular inflammatory diseases, neovascular glaucoma and cystoid macular edema;
•Is considered to require cataract surgery in the next 12 months by the researcher;
•Has received intravitreal injection of corticosteroids within three months before screening, subconjunctival injection of corticosteroids within six months, or local treatment with ocular corticosteroids within one month;
•Has received the following ophthalmic operations: scleral buckling, verteporfin-photodynamic therapy (PDT), vitrectomy, radial optic neurotomy/optic nerve sheathotomy, glaucoma filtration, parafoveal laser photocoagulation, pan-retinal photocoagulation, and macular translocation;

Arms & Interventions

Conbercept ophthalmic injection

Intervention: Conbercept ophthalmic injection

Sham Comparator

sham / Conbercept ophthalmic injection

Intervention: Conbercept ophthalmic injection

Sham Comparator

sham / Conbercept ophthalmic injection

Intervention: sham/Conbercept ophthalmic injection

Outcomes

Primary Outcomes

Best Corrected Visual Acuity

Time Frame: month 6

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

Best Corrected Visual Acuity (BCVA)(month 3 and month 12)
Central Retinal Thickness(month 3, month 6 and month 12)
resue treament(month 6 and month 12)
Number of participants with treatment-related the systemic and ocular safely as assessed(up to 12.5 months)
distribution of BCVA changes(month 3, month 6 and month 12)
mean changes in BCVA(month 0,month 1,month 2,month 3,month 4,month 5,month 6,month 7,month 8,month 9,month 10,month 11 and month 12)
Change in image(month 0,month 1,month 2,month 3,month 4,month 5,month 6,month 7,month 8,month 9,month 10,month 11 and month 12)