Clinical trial NCT01809223: A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV
Official title: The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Choroid Neovascularization Secondary to Degenerative Myopia
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-12
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 neovascularization secondary to pathological myopia.


Eligibility criteria: 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.

Primary outcomes:
measure: mean change from baseline of visual acuity
timeFrame: 3-month
Secondary outcomes:
measure: mean change from baseline of anatomical features
timeFrame: 3-month
measure: mean change from baseline of visual acuity
timeFrame: 9 months
measure: safety and tolerability of conbercept
timeFrame: 3-month and 9-month
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren hospital affiliated to Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: Southwest Hospital
state: Chongqing
city: Chongqing
country: China
facility: Daping Hospital, Research Institute of Surgery Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Military
state: Hubei
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
city: Qingdao
country: China
facility: Ophthalmologic Hospital of Qingdao
state: Shandong
city: Shanghai
country: China
facility: Shanghai First People's Hospital
state: Shanghai
city: Xian
country: China
facility: Xijing Hospital
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Wenzhou
country: China
facility: The Affiliated Eye Hospital of WMC
state: Zhejiang
Study officials:
References: