Status:
UNKNOWN
A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Conditions:
Choroid Neovascularization Secondary to Degenerative Myopia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 neovasc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2015
Estimated Enrollment :
176 Patients enrolled
Trial Details
Trial ID
NCT01809223
Start Date
August 1 2012
End Date
March 1 2015
Last Update
June 4 2014
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032
2
Peking University Third Hospital
Beijing, Beijing Municipality, China, 100083
3
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China, 100730
4
Southwest Hospital
Chongqing, Chongqing Municipality, China, 400038