Conbercept in Neovascular Age-related Macular Degeneration
Research type
Research Study
Full title
A Multicenter, Double-Masked, Randomized, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Conbercept Intravitreal Injection in Subjects with Neovascular Age-related Macular Degeneration
IRAS ID
248600
Contact name
Yan Cheng
Contact email
Sponsor organisation
Chengdu Kanghong Biotechnology Co., Ltd.
Eudract number
2017-004826-14
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 10 days
Research summary
Age-related macular degeneration (AMD) is the leading cause of severe and irreversible vision loss in people over the age of 65 in the United States (US) and in western countries. There are many challenges for the successful treatment of AMD, including the burden of frequent treatment and intravitreal (IVT)(into the eye) injections. Available therapies include laser photocoagulation (laser surgery), surgery and photodynamic therapy (PDT) (a treatment that involves the use of light-sensitive medication and a light source to destroy abnormal cells). None of these treatment options are singularly effective.
The purpose of this clinical study is to evaluate the efficacy and safety of 0.5 mg and 1.0 mg conbercept IVT injection compared with aflibercept (a commonly used treatment for wet AMD) IVT injection (2.0 mg, Eylea®), in participants with wet age-related macular degeneration (AMD).
The study will comprise of a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (followed by last assessment at 96 weeks).
The study will recruit approximately 1140 participants in a ratio of 1:1:1 (meaning there is an equal chance of receiving any of the treatment options) to receive intravitreal (IVT) injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept.
To maintain masking of treatment groups, “sham” procedures (similar in procedure to the actual injection, but no study medication is injected into the eye) will be performed on all participants at the visits where no active treatment is scheduled to be administered. The sham procedure will use a syringe without a needle, and the procedure helps to mask any differences in how often the participants are receiving a dose.
REC name
East of England - Cambridge South Research Ethics Committee
REC reference
18/EE/0378
Date of REC Opinion
9 Jan 2019
REC opinion
Further Information Favourable Opinion