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

NCT01809236 | Unknown Phase 2

• 1 other identifier: KHSWKH902008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline in BCVA

  3-month

Secondary Outcomes (5)

• 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

Study Arms (1)

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

Conbercept BIOLOGICAL

intravitreal injection of 0.5 mg Conbercept

0.5 mg Conbercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to provide signed Informed Consent Form.
• Age ≥ 18, both male and female。
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (2)

Beijing Tongren hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

The Affiliated Eye Hospital of WMC

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Conditions

Retinal Vein Occlusion

Interventions

KH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 12, 2013
• Study Start: May 1, 2012
• Primary Completion: November 1, 2013
• Study Completion: March 1, 2014
• Last Updated: March 27, 2014

Record last verified: 2014-03

Locations

CN (2)