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

NCT02098720 | Unknown Phase 2

• 1 other identifier: KHSWKH902009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain

  6-month

Secondary Outcomes (3)

• 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

Study Arms (1)

Conbercept

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.

Drug: Conbercept

Interventions

Conbercept DRUG

Conbercept

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients give fully informed consent and are willing and able to comply with all study procedures.
• 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).
• BCVA in study eye \< 19 letters (approximately 20/400 Snellen equivalent).

You may not qualify if:

• Past or existing non-exudative AMD in study eye decided by investigator that have affected macular detection or central vision;
• Subretinal hemorrhage in study eye and bleeding area ≥6 disc areas;
• History of vitreous hemorrhage within last month;
• The maximum diameter of scar and fibrosis area ≥500μm at subfoveal in study eye;
• 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;
• History of glaucoma in study eye;
• Aphakia (excluding artificial lens) in the study eye.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (1)

Zhongshan Ophthalmic Center,Sun yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

KH902 fusion protein

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 25, 2014
• First Posted: March 28, 2014
• Study Start: December 1, 2011
• Primary Completion: March 1, 2014
• Last Updated: July 22, 2014

Record last verified: 2014-07

Locations

CN (1)