Overview

This trial is active, not recruiting.

Condition choroid neovascularization secondary to degenerative myopia
Treatments conbercept, fixed, conbercept, prn, sham injection
Phase phase 3
Sponsor Chengdu Kanghong Biotech Co.,Ltd.
Start date August 2012
End date February 2014
Trial size 176 participants
Trial identifier NCT01809223, KHSWKH902007

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
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.
conbercept, fixed
intravitreal injection of 0.5 mg conbercept per month, fixed injection
conbercept, prn
intravitreal injection of 0.5 mg conbercept as need, PRN
(Sham Comparator)
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.
conbercept, fixed
intravitreal injection of 0.5 mg conbercept per month, fixed injection
conbercept, prn
intravitreal injection of 0.5 mg conbercept as need, PRN
sham injection
sham intravitreal injection per month, fixed injection

Primary Outcomes

Measure
mean change from baseline of visual acuity
time frame: 3-month

Secondary Outcomes

Measure
mean change from baseline of anatomical features
time frame: 3-month
mean change from baseline of visual acuity
time frame: 9 months
safety and tolerability of conbercept
time frame: 3-month and 9-month

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Chengdu Kanghong Biotech Co.,Ltd..