A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV

Study Overview
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Brief Summary
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This study is design to evaluate the effect of conbercept therapy on visual acuity and anatomic outcomes compared to sham injection and durability of response observed in subjects with choroid neovascularization secondary to pathological myopia.

Official Title
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The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia

Conditions
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Choroid Neovascularization Secondary to Degenerative Myopia

Intervention / Treatment
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* Drug: conbercept, Fixed
* Drug: conbercept, PRN
* Other: sham injection


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: Myopia of equal to or greater than -6.00D,and axial length ≥26.5mm. Diagnosis of active subfoveal, juxafoveal, or extrafoveal CNV secondary to high myopia. Visual impairment due to CNV secondary to high myopia. BCVA score ≥24 and ≤73 ETDRS letters (approximately 20/40  20/320 Snellen equivalent). Ocular media of sufficient quality to obtain fundus and OCT images. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent) Exclusion Criteria: Current vitreous hemorrhage in either eye. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye. Active infectious ocular inflammation in either eye. Fibrosis or atrophy involving the center of foveal in the study eye. Any concurrent intraocular condition in the study eye that, in the opinion of investigator, could either require medical or surgical intervention during the study period to prevent or treat visual loss that might result from that condition. The lesion size ≥30 mm2 in the study eye. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results. Uncontrolled glaucoma or cup/disk ratio > 0.8 in the study eye. Aphakia (excluding artificial lens) in the study eye. Serious amblyopia and amaurosis in the fellow eye.

Ages Eligible for Study
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Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conbercept treatment group<br>Subjects will receive conbercept injections at a dose of 0.5 mg/eye, once a month for first 3 months. In the next 6 months, the investigator will decide whether repeat injections are needed base on the monthly assessment results. | Drug: conbercept, Fixed<br>* intravitreal injection of 0.5 mg conbercept per month, fixed injection<br>Drug: conbercept, PRN<br>* intravitreal injection of 0.5 mg conbercept as need, PRN<br>|
| Sham Comparator: sham injection group<br>Subjects will receive sham injections monthly for 3 months and will receive 0.5 mg/eye conbercept at month 4. The investigator will decide whether repeat injections are needed base on the monthly assessment results from month 5 to month 9. | Drug: conbercept, Fixed<br>* intravitreal injection of 0.5 mg conbercept per month, fixed injection<br>Drug: conbercept, PRN<br>* intravitreal injection of 0.5 mg conbercept as need, PRN<br>Other: sham injection<br>* sham intravitreal injection per month, fixed injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change from baseline of visual acuity | to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3 | 3-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mean change from baseline of anatomical features | to compare the difference of mean change from baseline of CRT, CNV size and lesion size between conbercept treatment group and sham injection group at month 3 | 3-month | 
| mean change from baseline of visual acuity | to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9 | 9 months | 
| safety and tolerability of conbercept | to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9 | 3-month and 9-month |