ShORe

• 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 Ranibizumab, Compared with Ranibizumab Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)

• IRAS ID

  1003701

• Contact name

  Clare Price

• Contact email

  clare.price@opthea.com

• Sponsor organisation

  Opthea Limited

• Eudract number

  2020-004736-24

• Clinicaltrials.gov Identifier

  NCT04757610

• Research summary

  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 ranibizumab. 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 ranibizumab (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 dummy/pretend 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 allocated at random (1:1:1 ratio) to one of three groups and receive ranibizumab with or without the study drug.

  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.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  21/SC/0182

• Date of REC Opinion

  19 Jul 2021

• REC opinion

  Further Information Favourable Opinion