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

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

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.

Study Overview

• Status: Unknown
• Conditions: Choroid Neovascularization Secondary to Degenerative Myopia
• Intervention / Treatment: Drug: conbercept, Fixed; Drug: conbercept, PRN; Other: sham injection

• Study Type: Interventional
• Enrollment (Anticipated): 176
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3-month
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	9 months
safety and tolerability of conbercept	to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9	3-month and 9-month

Collaborators and Investigators

• Sponsor: Chengdu Kanghong Biotech Co., Ltd.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): February 1, 2014
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: March 11, 2013
• First Posted (Estimate): March 12, 2013

Study Record Updates

• Last Update Posted (Estimate): June 4, 2014
• Last Update Submitted That Met QC Criteria: June 3, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Eye Diseases; Uveal Diseases; Neoplastic Processes; Choroid Diseases; Refractive Errors; Metaplasia; Neoplasm Metastasis; Choroidal Neovascularization; Neovascularization, Pathologic; Myopia; Myopia, Degenerative
• Other Study ID Numbers: KHSWKH902007