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

Phase 3

• Conditions: Choroid Neovascularization Secondary to Degenerative Myopia
• Interventions: Drug: conbercept, Fixed; Drug: conbercept, PRN; Other: sham injection

• Registration Number: NCT01809223
• Lead Sponsor: Chengdu Kanghong Biotech Co., Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-03-11
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-12
• Primary Completion: 2014-02
• Status Verified: 2014-03
• Last Update Submitted: 2014-06-03
• Last Update Posted: 2014-06-04
• Study Completion: 2015-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conbercept treatment group	conbercept, Fixed	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 treatment group	conbercept, PRN	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.
sham injection group	conbercept, Fixed	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.
sham injection group	conbercept, PRN	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.
sham injection group	sham injection	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.

Primary Outcome Measures

Name	Time	Method
mean change from baseline of visual acuity	3-month	to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3

Secondary Outcome Measures

Name	Time	Method
mean change from baseline of anatomical features	3-month	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
mean change from baseline of visual acuity	9 months	to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9
safety and tolerability of conbercept	3-month and 9-month	to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9

Trial Locations

Locations (13)

Shanghai First People's Hospital; 🇨🇳 Shanghai, Shanghai, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, Sichuan, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

Ophthalmologic Hospital of Qingdao; 🇨🇳 Qingdao, Shandong, China

Wuhan General Hospital of Guangzhou Military; 🇨🇳 Wuhan, Hubei, China

Southwest Hospital; 🇨🇳 Chongqing, Chongqing, China

Daping Hospital, Research Institute of Surgery Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Wuxi No.2 People's Hospital; 🇨🇳 Wuxi, Jiangsu, China

Xijing Hospital; 🇨🇳 Xian, Shanxi, China

Beijing Tongren hospital affiliated to Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, Beijing, China

Zhongshan Ophthalmic Center; 🇨🇳 Guangzhou, Guangdong, China

The Affiliated Eye Hospital of WMC; 🇨🇳 Wenzhou, Zhejiang, China