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

Retinal Vein Occlusion Clinical Trial

— FALCON  

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01809236
• Other study ID #: KHSWKH902008
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 11, 2013
• Last updated: March 25, 2014
• Start date: May 2012
• Est. completion date: March 2014

Study information

• Verified date: March 2014
• Source: Chengdu Kanghong Biotech Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: March 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Retinal Vein Occlusion

Intervention

Biological:
• Conbercept
intravitreal injection of 0.5 mg Conbercept

Locations

Country	Name	City	State
China	Beijing Tongren hospital affiliated to Capital Medical University	Beijing	Beijing
China	The Affiliated Eye Hospital of WMC	Wenzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in BCVA		3-month	No
Secondary	Mean change from baseline in BCVA		baseline to 9-month	No
Secondary	Mean change from baseline in central retinal thickness		baseline to 9-month	No
Secondary	Mean injection times		baseline to 9-month	No
Secondary	Mean change from baseline in Macular edema volume and other anatomical character in the study eye		baseline to 9-month	No
Secondary	Rate of adverse event		3-month and 9-month	Yes