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

NCT01809223 | Unknown Phase 3

• 1 other identifier: KHSWKH902007
• Study Type: interventional
• Target: 176
• Locations: 1 country
• Sites: 13

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.

Conditions

Choroid Neovascularization Secondary to Degenerative Myopia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• mean change from baseline of anatomical features

  3-month

• mean change from baseline of visual acuity

  9 months

• safety and tolerability of conbercept

  3-month and 9-month

Study Arms (2)

conbercept treatment group

EXPERIMENTAL

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; Drug: conbercept, PRN

sham injection group

SHAM COMPARATOR

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; Drug: conbercept, PRN; Other: sham injection

Interventions

conbercept, Fixed DRUG

intravitreal injection of 0.5 mg conbercept per month, fixed injection

conbercept treatment group; sham injection group

conbercept, PRN DRUG

intravitreal injection of 0.5 mg conbercept as need, PRN

conbercept treatment group; sham injection group

sham injection OTHER

sham intravitreal injection per month, fixed injection

sham injection group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chengdu Kanghong Biotech Co., Ltd.: lead

Study Sites (13)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100083, China

Location

Beijing Tongren hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Southwest Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Daping Hospital, Research Institute of Surgery Third Military Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

Zhongshan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

Location

Wuhan General Hospital of Guangzhou Military

Wuhan, Hubei, 430070, China

Location

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, 214002, China

Location

Ophthalmologic Hospital of Qingdao

Qingdao, Shandong, 266071, China

Location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, 200080, China

Location

Xijing Hospital

Xian, Shanxi, 710032, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

The Affiliated Eye Hospital of WMC

Wenzhou, Zhejiang, 325027, China

Location

MeSH Terms

Interventions

KH902 fusion protein; salicylhydroxamic acid

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2013
• First Posted: March 12, 2013
• Study Start: August 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2015
• Last Updated: June 4, 2014

Record last verified: 2014-03

Locations

CN (13)