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

Very Low Vision Secondary to Wet Age-related Macular Degeneration Clinical Trial

— LAMP  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02098720
• Other study ID #: KHSWKH902009
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 25, 2014
• Last updated: July 21, 2014
• Start date: December 2011

Study information

• Verified date: July 2014
• Source: Chengdu Kanghong Biotech Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neoplasm Metastasis
• Very Low Vision Secondary to Wet Age-related Macular Degeneration
• Vision, Low

Intervention

Drug:
• Conbercept

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center,Sun yat-sen University	Guangzhou city	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co.,Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percentage of patients with best corrected visual acuity (BCVA ) =19 letters gain		6-month	No
Secondary	mean change in BCVA from baseline		6-month	No
Secondary	change from baseline of macular area thickness and other anatomy results		6-month	No
Secondary	safety of Conbercept therapy	To assess incidence of adverse events, incidence of adverse drug reactions etc.	6-month	Yes