NCT02934841

Conbercept in Choroidal Neovascularization Secondary to Uveitis

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The investigators hypothesize that it is safe and effective to treat patients with choroidal neovascularisation (abnormal blood vessels growing under the retina) secondary to uveitis with Conbercept. This will be a randomized, placebo-controlled trial. 20 patients will receive three injections of Conbercept into the affected eye (and repeated injections if required), and 20 patients will receive three sham injections requiring no needle stick, but making the patient unaware of whether or not he received active treatment. Outcome of the two treatment groups will be compared after one year.

Detailed description

Primary Outcome Measures: Mean change from baseline in best corrected visual acuity \[ Time Frame: 12 months \] Secondary Outcome Measures: Mean change from baseline in retinal thickness \[ Time Frame: 12 months \] Mean number of Conbercept injections required over 12 months \[ Time Frame: 12 months \] Ocular and systemic adverse events \[ Time Frame: 12 months \] Enrollment: 40 Intervention Details: Drug: Conbercept 20 patients will receive an intravitreal injections of conbercept 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with conbercept 0.5 mg based on measurements of visual acuity, Optical coherence tomography (OCT) findings, FFA and clinical appearance.

Conditions

• Choroidal Neovascularization
• Uveitis

Interventions

Type	Name	Description
DRUG	Conbercept
DRUG	sham

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-03-01
• Completion: 2018-11-01
• First posted: 2016-10-17
• Last updated: 2016-10-17