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

Phase 2

• Conditions: Very Low Vision Secondary to Wet Age-related Macular Degeneration
• Interventions: Drug: Conbercept

• Registration Number: NCT02098720
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Primary Completion: 2014-03
• Study First Submitted: 2014-03-25
• Study First Submitted QC: 2014-03-27
• Study First Posted: 2014-03-28
• Status Verified: 2014-07
• Last Update Submitted: 2014-07-21
• Last Update Posted: 2014-07-22

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Conbercept	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.

Primary Outcome Measures

Name	Time	Method
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain	6-month

Secondary Outcome Measures

Name	Time	Method
mean change in BCVA from baseline	6-month
change from baseline of macular area thickness and other anatomy results	6-month
safety of Conbercept therapy	6-month	To assess incidence of adverse events, incidence of adverse drug reactions etc.

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center,Sun yat-sen University; 🇨🇳 Guangzhou city, Guangdong, China