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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier:
NCT01809223
First received: March 11, 2013
Last updated: June 3, 2014
Last verified: March 2014
  Purpose

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 Intervention Phase
Choroid Neovascularization Secondary to Degenerative Myopia
Drug: conbercept, Fixed
Drug: conbercept, PRN
Other: sham injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Safety and Efficacy of Conbercept in the Treatment of Choroidal Neovascularization (CNV) Secondary to High Myopia

Resource links provided by NLM:


Further study details as provided by Chengdu Kanghong Biotech Co.,Ltd.:

Primary Outcome Measures:
  • mean change from baseline of visual acuity [ Time Frame: 3-month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3-month ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    to evaluate the mean change from baseline of BCVA of two groups from month 1 to month 9

  • safety and tolerability of conbercept [ Time Frame: 3-month and 9-month ] [ Designated as safety issue: Yes ]
    to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9


Estimated Enrollment: 176
Study Start Date: August 2012
Estimated Study Completion Date: March 2015
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01809223

Locations
China, Beijing
Beijing Tongren hospital affiliated to Capital Medical University
Beijing, Beijing, China, 100730
Peking University Third Hospital
Beijing, Beijing, China, 100083
Peking Union Medical College Hospital
Beijing, Beijing, China, 100032
China, Chongqing
Daping Hospital, Research Institute of Surgery Third Military Medical University
Chongqing, Chongqing, China, 400042
Southwest Hospital
Chongqing, Chongqing, China, 400038
China, Guangdong
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, China, 510060
China, Hubei
Wuhan General Hospital of Guangzhou Military
Wuhan, Hubei, China, 430070
China, Jiangsu
Wuxi No.2 People's Hospital
Wuxi, Jiangsu, China, 214002
China, Shandong
Ophthalmologic Hospital of Qingdao
Qingdao, Shandong, China, 266071
China, Shanghai
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
China, Shanxi
Xijing Hospital
Xian, Shanxi, China, 710032
China, Sichuan
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 610041
China, Zhejiang
The Affiliated Eye Hospital of WMC
Wenzhou, Zhejiang, China, 325027
Sponsors and Collaborators
Chengdu Kanghong Biotech Co.,Ltd.
  More Information

No publications provided

Responsible Party: Chengdu Kanghong Biotech Co.,Ltd.
ClinicalTrials.gov Identifier: NCT01809223     History of Changes
Other Study ID Numbers: KHSWKH902007
Study First Received: March 11, 2013
Last Updated: June 3, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Myopia
Neovascularization, Pathologic
Myopia, Degenerative
Choroidal Neovascularization
Refractive Errors
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on July 29, 2014