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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-03-31

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.

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Detailed Description

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Conditions

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Choroid Neovascularization Secondary to Degenerative Myopia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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conbercept treatment group

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.

Group Type EXPERIMENTAL

conbercept, Fixed

Intervention Type DRUG

intravitreal injection of 0.5 mg conbercept per month, fixed injection

conbercept, PRN

Intervention Type DRUG

intravitreal injection of 0.5 mg conbercept as need, PRN

sham injection group

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.

Group Type SHAM_COMPARATOR

conbercept, Fixed

Intervention Type DRUG

intravitreal injection of 0.5 mg conbercept per month, fixed injection

conbercept, PRN

Intervention Type DRUG

intravitreal injection of 0.5 mg conbercept as need, PRN

sham injection

Intervention Type OTHER

sham intravitreal injection per month, fixed injection

Interventions

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conbercept, Fixed

intravitreal injection of 0.5 mg conbercept per month, fixed injection

Intervention Type DRUG

conbercept, PRN

intravitreal injection of 0.5 mg conbercept as need, PRN

Intervention Type DRUG

sham injection

sham intravitreal injection per month, fixed injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients give fully informed consent and are willing and able to comply with all study procedures.
2. 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.
3. The BCVA score of fellow eyes ≥ 19 ETDRS letters (approximately 20/400 Snellen equivalent)

Exclusion Criteria

1. Current vitreous hemorrhage in either eye.
2. Intraocular treatment with corticosteroids within last 3 months or periocular treatment with corticosteroids within last month in the study eye.
3. Active infectious ocular inflammation in either eye.
4. Fibrosis or atrophy involving the center of foveal in the study eye.
5. 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.
6. The lesion size ≥30 mm2 in the study eye.
7. Any ocular disorder in the study eye that, in the opinion of the investigator, may confound interpretation of the study results.
8. Uncontrolled glaucoma or cup/disk ratio \> 0.8 in the study eye.
9. Aphakia (excluding artificial lens) in the study eye.
10. Serious amblyopia and amaurosis in the fellow eye.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No