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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Chengdu Kanghong Biotech Co.,Ltd.

Current Primary Outcome: mean change from baseline of visual acuity [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • mean change from baseline of anatomical features [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 3-month and 9-month ]
    to evaluate the incidence of AEs (ocular or non-ocular) of two groups at month 3 and 9


Original Secondary Outcome: Same as current

Information By: Chengdu Kanghong Biotech Co.,Ltd.

Dates:
Date Received: March 11, 2013
Date Started: August 2012
Date Completion: March 2015
Last Updated: June 3, 2014
Last Verified: March 2014