Overview

This trial is active, not recruiting.

Condition very low vision secondary to wet age-related macular degeneration
Treatment conbercept
Phase phase 2
Sponsor Chengdu Kanghong Biotech Co.,Ltd.
Start date December 2011
End date March 2014
Trial size 30 participants
Trial identifier NCT02098720, KHSWKH902009

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
conbercept

Primary Outcomes

Measure
percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain
time frame: 6-month

Secondary Outcomes

Measure
mean change in BCVA from baseline
time frame: 6-month
change from baseline of macular area thickness and other anatomy results
time frame: 6-month
safety of Conbercept therapy
time frame: 6-month

Eligibility Criteria

Male or female participants at least 50 years old.

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.

Additional Information

Official title An Open, Non-randomize, Single-center, Safety and Efficacy Study of Conbercept in Patients With Very Low Vision Secondary to Wet Age-related Macular Degeneration
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Chengdu Kanghong Biotech Co.,Ltd..