COAST
Research type
Research Study
Full title
A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
IRAS ID
1003719
Contact name
Clare Price
Contact email
Sponsor organisation
Opthea
Eudract number
2020-004694-46
Clinicaltrials.gov Identifier
Research summary
Summary of Research
This study will look at an investigational drug called OPT-302 and how safe it is and how well it works in treating patients with age-related macular degeneration (AMD) . AMD results from a disease of the macula, a yellow part at the back of the eye that is responsible for sharp vision and seeing in colour. Wet AMD occurs when abnormal blood vessels grow under the macula and retina, a part of the eye that helps to see. The abnormal blood vessels leak blood and fluid, causing problems with vision.
There are several approved medications that are used to treat wet AMD such as aflibercept. However, these medications may not work to improve vision in all patients or may not improve vision enough, and hence new treatment options are needed.
The study will also look at how the study drug is processed by the body (called ‘pharmacokinetics’ or ‘PK’ testing).
In this study, the study drug and aflibercept (approved medication to treat wet AMD) will be given as separate injections into the eye. To determine the potential benefits of the study drug, some participants may receive a control or dummy injection of the study drug. This will be done to assess whether there is an additional effect of the study drug when given along with an approved therapy. Participants will be assigned to one of three groups at random and receive aflibercept with or without the study drug (1:1:1 ratio).About 990 people from different study centres around the world are expected to take part in this study. The expected duration of participation for each participant is a little less than 2 years (about 23 months and 2 weeks). While in the study participants will have up to 27 visits to the study centre.
Summary of Results
The purpose of this study was to evaluate the safety and efficacy of the investigational drug OPT-302 in patients with neovascular age related macular degeneration (nAMD). AMD is an eye disease that can cause blindness. OPT-302 was hypothesized to provide additional vision gains beyond the standard of care treatment. A total of 986 male and female adults over 50 years of age enrolled in the study globally. There were no safety concerns, however the results from this study showed that OPT-302+ranibizumab (a comparator that is the standard therapy for AMD) did not improve vision in patients compared to ranibizumab alone. As a result, the study was stopped early. Even though the efficacy of the OPT-302 was not demonstrated, the incidence and nature of adverse events observed in the Study Eye were in line with those reported for the standard of care and the injection procedure.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
21/EE/0171
Date of REC Opinion
23 Aug 2021
REC opinion
Further Information Favourable Opinion