Status:
UNKNOWN
Efficacy and Safety of Conbercept in Macular Edema Secondary to Retinal Vein Occlusion
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Conditions:
Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 month...
Eligibility Criteria
Inclusion
- Ability and willingness to provide signed Informed Consent Form.
- Age ≥ 18, both male and female。
- 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
- Brisk afferent pupillary defect.
- 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.
- 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.
- Any active infection involving the ocular including blepharitis, infectious conjunctivitis, keratitis, scleritis, endophthalmitis in either eye.
- Any inflammatory cells detected in the anterior chamber and/or vitreous in the study eye.
- 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.
- Neovascular change in the study eye and/or neovascularization of the iris or neovascular glaucoma in study eye at baseline.
- 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.
- Patients diagnosed with systemic immune diseases and any uncontrolled clinical disease.
- Pregnant or nursing women.
- Patients need to exclude in the opinion of investigator.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01809236
Start Date
May 1 2012
End Date
March 1 2014
Last Update
March 27 2014
Active Locations (2)
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1
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730
2
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, China, 325027