Clinical Trials
BioCryst
A Phase 1B Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat in Participants with Diabetic Macular Edema
Overview
This research study is testing a potential new treatment for Diabetic Macular Oedema (DME).
The new treatment is called avoralstat.
Avoralstat is a plasma kallikrein inhibitor.
It works by binding to a specific enzyme called plasma kallikrein which it is hoped will prevent vessels in your eye from leaking fluid and control inflammation present in the eye tissue.
The study drug will be administered as a single suprachoroidal injection, meaning it will be injected into the space between the choroid and the sclera (the white outer layer) of the eye, via a specially developed syringe-like device called the SCS Microinjector.
Only one of your eyes will receive the injection.
The purpose of this clinical research study is to evaluate the safety of the study drug at different dose levels, to understand how your body handles the study drug, and to see how you and your DME responds to an injection of avoralstat.
This is the first time avoralstat will be given to people to treat DME as an injection in the eye.
Avoralstat was previously studied for the treatment of another disease and given as capsules by mouth.
The duration of this study is 6 months.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Dr Amy Cohn
This research study is testing a potential new treatment for Diabetic Macular Oedema (DME).
The new treatment is called avoralstat.
Avoralstat is a plasma kallikrein inhibitor.
It works by binding to a specific enzyme called plasma kallikrein which it is hoped will prevent vessels in your eye from leaking fluid and control inflammation present in the eye tissue.
The study drug will be administered as a single suprachoroidal injection, meaning it will be injected into the space between the choroid and the sclera (the white outer layer) of the eye, via a specially developed syringe-like device called the SCS Microinjector.
Only one of your eyes will receive the injection.
The purpose of this clinical research study is to evaluate the safety of the study drug at different dose levels, to understand how your body handles the study drug, and to see how you and your DME responds to an injection of avoralstat.
This is the first time avoralstat will be given to people to treat DME as an injection in the eye.
Avoralstat was previously studied for the treatment of another disease and given as capsules by mouth.
The duration of this study is 6 months.
For further information please contact Cerulea on 99298076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator