An Open, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration (wAMD)

NCT ID: NCT02098720

Last Updated: 2014-07-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31

Brief Summary

This study is designed to evaluate the effect of Conbercept therapy on visual acuity and anatomic outcomes and safety observed in subjects with very low vision secondary to wet age-related macular degeneration.

Conditions

Very Low Vision Secondary to Wet Age-related Macular Degeneration

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conbercept

Subjects will receive Conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 3 months, the investigator will decide whether repeat injections are needed based on the monthly assessment results.

Group Type: EXPERIMENTAL

Conbercept

Intervention Type: DRUG

Interventions

Conbercept

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Patients give fully informed consent and are willing and able to comply with all study procedures.

2. In the study eye:

There are primary or recurrent subfoveal or parafoveal active choroidal neovascularization (CNV) lesions secondary to wAMD.

The criterion of active CNV should meet at least one of following three conditions :

• fresh bleeding;
• neurosensory detachment showed on optical coherence tomography(OCT);
• leakage showed on fundus fluorescein angiography (FFA).

3. BCVA in study eye < 19 letters (approximately 20/400 Snellen equivalent).

Exclusion Criteria

1. Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;

2. Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;

3. History of vitreous hemorrhage within last month;

4. The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;

5. Photodynamic therapy (PDT) or drug treatment of CNV within last 6 months in study eye, or anti-vascular endothelial growth factor (VEGF) therapy in fellow eye within last month;

6. History of glaucoma in study eye;

7. Aphakia (excluding artificial lens) in the study eye.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chengdu Kanghong Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Ophthalmic Center,Sun yat-sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

KHSWKH902009

Identifier Type: -

Identifier Source: org_study_id