Efficacy and Safety of Conbercept in Macular Edema Second... | NCT01809236

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

NCT01809236

Sponsor

Chengdu Kanghong Biotech Co., Ltd.

Status

Unknown status

Last Update Posted

Mar 27, 2014Estimated

Enrollment

60Estimated

Phase

Phase 2

Conditions

Retinal Vein Occlusion

Interventions

Conbercept

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Mar 2014Estimated

First Submitted Date

Mar 11, 2013

First Submission Date that Met QC Criteria

Mar 11, 2013

First Posted Date

Mar 12, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
0.5 mg Conbercept	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Conbercept	Biological	intravitreal injection of 0.5 mg Conbercept	0.5 mg Conbercept

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

Measure	Description	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

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D020246	Venous Thrombosis
D013927	Thrombosis