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

Sponsor

Chengdu Kanghong Biotech Co., Ltd. (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01809223

Collaborator

(none)

176

Enrollment

Locations

Arms

30.9

Duration (Months)

13.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Choroid Neovascularization Secondary to Degenerative Myopia	Drug: conbercept, Fixed Drug: conbercept, PRN Other: sham injection	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

176 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Feb 1, 2014

Anticipated Study Completion Date :

Mar 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: conbercept, Fixed intravitreal injection of 0.5 mg conbercept per month, fixed injection Drug: conbercept, PRN intravitreal injection of 0.5 mg conbercept as need, PRN
Sham Comparator: 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.	Drug: conbercept, Fixed intravitreal injection of 0.5 mg conbercept per month, fixed injection Drug: conbercept, PRN intravitreal injection of 0.5 mg conbercept as need, PRN Other: sham injection sham intravitreal injection per month, fixed injection

Arm

Intervention/Treatment

Experimental: 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.

Drug: conbercept, Fixed

intravitreal injection of 0.5 mg conbercept per month, fixed injection

Drug: conbercept, PRN

intravitreal injection of 0.5 mg conbercept as need, PRN

Sham Comparator: 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.

Drug: conbercept, Fixed

intravitreal injection of 0.5 mg conbercept per month, fixed injection

Drug: conbercept, PRN

intravitreal injection of 0.5 mg conbercept as need, PRN

Other: sham injection

sham intravitreal injection per month, fixed injection

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Union Medical College Hospital	Beijing	Beijing	China	100032
2	Peking University Third Hospital	Beijing	Beijing	China	100083
3	Beijing Tongren hospital affiliated to Capital Medical University	Beijing	Beijing	China	100730
4	Southwest Hospital	Chongqing	Chongqing	China	400038
5	Daping Hospital, Research Institute of Surgery Third Military Medical University	Chongqing	Chongqing	China	400042
6	Zhongshan Ophthalmic Center	Guangzhou	Guangdong	China	510060
7	Wuhan General Hospital of Guangzhou Military	Wuhan	Hubei	China	430070
8	Wuxi No.2 People's Hospital	Wuxi	Jiangsu	China	214002
9	Ophthalmologic Hospital of Qingdao	Qingdao	Shandong	China	266071
10	Shanghai First People's Hospital	Shanghai	Shanghai	China	200080
11	Xijing Hospital	Xian	Shanxi	China	710032
12	West China Hospital of Sichuan University	Chengdu	Sichuan	China	610041
13	The Affiliated Eye Hospital of WMC	Wenzhou	Zhejiang	China	325027