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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Very Low Vision Secondary to Wet Age-related Macular Degeneration

Intervention / Treatment
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* Drug: Conbercept


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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). Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conbercept<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patients with best corrected visual acuity (BCVA ) ≥19 letters gain |  | 6-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | To assess incidence of adverse events, incidence of adverse drug reactions etc. | 6-month |