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

Primary Purpose

Choroid Neovascularization Secondary to Degenerative Myopia

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
conbercept, Fixed
conbercept, PRN
sham injection
Sponsored by
Chengdu Kanghong Biotech Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Choroid Neovascularization Secondary to Degenerative Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Peking Union Medical College Hospital
  • Peking University Third Hospital
  • Beijing Tongren hospital affiliated to Capital Medical University
  • Southwest Hospital
  • Daping Hospital, Research Institute of Surgery Third Military Medical University
  • Zhongshan Ophthalmic Center
  • Wuhan General Hospital of Guangzhou Military
  • Wuxi No.2 People's Hospital
  • Ophthalmologic Hospital of Qingdao
  • Shanghai First People's Hospital
  • Xijing Hospital
  • West China Hospital of Sichuan University
  • The Affiliated Eye Hospital of WMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

conbercept treatment group

sham injection group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 11, 2013
Last Updated
June 3, 2014
Sponsor
Chengdu Kanghong Biotech Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01809223
Brief Title
A Randomized, Double-blind, Multicenter, Sham-controlled, Safety and Efficacy Study of Conbercept in Patients With mCNV
Acronym
SHINY
Official Title
The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chengdu Kanghong Biotech Co., Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Choroid Neovascularization Secondary to Degenerative Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
conbercept treatment group
Arm Type
Experimental
Arm Description
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.
Arm Title
sham injection group
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
conbercept, Fixed
Intervention Description
intravitreal injection of 0.5 mg conbercept per month, fixed injection
Intervention Type
Drug
Intervention Name(s)
conbercept, PRN
Intervention Description
intravitreal injection of 0.5 mg conbercept as need, PRN
Intervention Type
Other
Intervention Name(s)
sham injection
Intervention Description
sham intravitreal injection per month, fixed injection
Primary Outcome Measure Information:
Title
mean change from baseline of visual acuity
Description
to compare the mean change from baseline of best-corrected visual acuity (BCVA) between conbercept treatment group and sham injection group at month 3
Time Frame
3-month
Secondary Outcome Measure Information:
Title
mean change from baseline of anatomical features
Description
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
Time Frame
3-month
Title
mean change from baseline of visual acuity
Description
to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9
Time Frame
9 months
Title
safety and tolerability of conbercept
Description
to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9
Time Frame
3-month and 9-month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100032
Country
China
Facility Name
Peking University Third Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Beijing Tongren hospital affiliated to Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Southwest Hospital
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Daping Hospital, Research Institute of Surgery Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400042
Country
China
Facility Name
Zhongshan Ophthalmic Center
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Facility Name
Wuhan General Hospital of Guangzhou Military
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430070
Country
China
Facility Name
Wuxi No.2 People's Hospital
City
Wuxi
State/Province
Jiangsu
ZIP/Postal Code
214002
Country
China
Facility Name
Ophthalmologic Hospital of Qingdao
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266071
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Xijing Hospital
City
Xian
State/Province
Shanxi
ZIP/Postal Code
710032
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The Affiliated Eye Hospital of WMC
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325027
Country
China

12. IPD Sharing Statement

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

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