Uveitis Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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