Clinical trial NCT01809236: Efficacy and Safety of Conbercept in Macular Edema Secondary to Retinal Vein Occlusion
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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Retinal Vein Occlusion
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline in BCVA
timeFrame: 3-month
Secondary outcomes:
measure: Mean change from baseline in BCVA
timeFrame: baseline to 9-month
measure: Mean change from baseline in central retinal thickness
timeFrame: baseline to 9-month
measure: Mean injection times
timeFrame: baseline to 9-month
measure: Mean change from baseline in Macular edema volume and other anatomical character in the study eye
timeFrame: baseline to 9-month
measure: Rate of adverse event
timeFrame: 3-month and 9-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren hospital affiliated to Capital Medical University
state: Beijing
city: Wenzhou
country: China
facility: The Affiliated Eye Hospital of WMC
state: Zhejiang
Study officials:
References: