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

Primary Purpose

Retinal Vein Occlusion

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Conbercept

About this trial

This is an interventional treatment trial for Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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.

Sites / Locations

Beijing Tongren hospital affiliated to Capital Medical University
The Affiliated Eye Hospital of WMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

0.5 mg Conbercept

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean change from baseline in BCVA

Secondary Outcome Measures

Mean change from baseline in BCVA

Mean change from baseline in central retinal thickness

Mean injection times

Mean change from baseline in Macular edema volume and other anatomical character in the study eye

Rate of adverse event

Full Information

NCT ID

NCT01809236

First Posted

March 11, 2013

Last Updated

March 25, 2014

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT01809236

Brief Title

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

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Unknown status

Study Start Date

May 2012 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

March 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Retinal Vein Occlusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.5 mg Conbercept

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Conbercept

Intervention Description

intravitreal injection of 0.5 mg Conbercept

Primary Outcome Measure Information:

Title

Mean change from baseline in BCVA

Time Frame

3-month

Secondary Outcome Measure Information:

Title

Mean change from baseline in BCVA

Time Frame

baseline to 9-month

Title

Mean change from baseline in central retinal thickness

Time Frame

baseline to 9-month

Title

Mean injection times

Time Frame

baseline to 9-month

Title

Mean change from baseline in Macular edema volume and other anatomical character in the study eye

Time Frame

baseline to 9-month

Title

Rate of adverse event

Time Frame

3-month and 9-month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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.

Facility Information:

Facility Name

Beijing Tongren hospital affiliated to Capital Medical University

City

Beijing

State/Province

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

The Affiliated Eye Hospital of WMC

City

Wenzhou

State/Province

Zhejiang

ZIP/Postal Code

325027

Country

China

12. IPD Sharing Statement

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

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