Efficacy and Safety of Conbercept in Macular Edema Secondary to Retinal Vein Occlusion (FALCON)

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)

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.

Study Overview

• Status: Unknown
• Conditions: Retinal Vein Occlusion
• Intervention / Treatment: Biological: Conbercept

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital affiliated to Capital Medical University
  • Zhejiang
    • Wenzhou, Zhejiang, China, 325027
      • The Affiliated Eye Hospital of WMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 0.5 mg Conbercept; 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.	Biological: Conbercept; intravitreal injection of 0.5 mg Conbercept

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in BCVA	3-month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (ACTUAL): November 1, 2013
• Study Completion (ANTICIPATED): March 1, 2014

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (ESTIMATE): March 12, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): March 27, 2014
• Last Update Submitted That Met QC Criteria: March 25, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Retinal Vein Occlusion
• Other Study ID Numbers: KHSWKH902008