Overview

This trial is active, not recruiting.

Condition retinal vein occlusion
Treatment conbercept
Phase phase 2
Sponsor Chengdu Kanghong Biotech Co.,Ltd.
Start date May 2012
End date November 2013
Trial size 60 participants
Trial identifier NCT01809236, KHSWKH902008

Summary

This is a Phase II, single arm, open label clinical trial. 60 RVO patients (including 30 BRVO and 30 CRVO, respectively) are enrolled in the study. The study included a fixed treatment period (3 months) and a PRN period (6 months). In the fixed treatment period patients will receive 3 consecutive monthly intravitreal of 0.5 mg Conbercept. In the PRN period, patients are monthly visited and retreatment will be needed according to the retreatment criteria pre-specified.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
patients will receive monthly intravitreal injections of Conbercept to month 3 (total 3 times) and then on an as needed (PRN) dosing schedule based on the pre-specified retreatment criteria till to month 9.
conbercept
intravitreal injection of 0.5 mg Conbercept

Primary Outcomes

Measure
Mean change from baseline in BCVA
time frame: 3-month

Secondary Outcomes

Measure
Mean change from baseline in BCVA
time frame: baseline to 9-month
Mean change from baseline in central retinal thickness
time frame: baseline to 9-month
Mean injection times
time frame: baseline to 9-month
Mean change from baseline in Macular edema volume and other anatomical character in the study eye
time frame: baseline to 9-month
Rate of adverse event
time frame: 3-month and 9-month

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Ability and willingness to provide signed Informed Consent Form. 2. Age ≥ 18, both male and female。 3. Ocular Inclusion Criterion (Study Eye): - Diagnosis of Foveal center-involved macular edema due to RVO (both CRVO and BRVO) within 6 months. - Best corrected visual acuity (BCVA) letter score in the study eye of ≤ 73(Snellen equivalents 20/40). - Central retinal thickness by OCT in the study eye ≥ 320 μm. Exclusion Criteria: 1. Brisk afferent pupillary defect. 2. History of any anti-VEGF treatment in the study and/or system within 6 months before enrollment, and/or in the fellow eye within 3 month. 3. History of intraocular and/or peri-ocular corticosteroid use in the study eye within 3 months, and/or history of use steroids systemic (p.o., i.m., i.v.) within 1 month. 4. Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye. 5. Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye. 6. Presence of non-RVO disease, in the opinion of the investigator, might cause macular edema, such as AMD (wet or dry), diabetes retinopathy, uveitis etc. 7. Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline. 8. Patients with substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by equal or more than 3 lines or medicine or surgery treatment are needed in the study eye within 4 months. 9. Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease. 10. Pregnant or nursing women. 11. Patients need to exclude in the opinion of investigator.

Additional Information

Official title An Open Label, Single Arm Clinical Study of Intravitreal Injection of Conbercept in Patients With Maculae Edema Secondary to Retinal Vein Occlusion (the FALCON Study)
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Chengdu Kanghong Biotech Co.,Ltd..