Clinical Trials
CIRCLE
A randomized, participant and investigator masked, placebo-controlled, multicenter, Phase II dose-range finding study to assess the safety and efficacy of FWY003 in patients with geographic atrophy secondary to age-related macular degeneration.
Overview
The purpose of this study is to learn about the effects and safety of a new potential treatment for people with geographic atrophy (GA) due to age-related macular degeneration (AMD). The potential new treatment is called FWY003.
To learn the effects of FWY003 on GA, researchers will measure the growth of the geographic atrophy area on images of the retina (eye) during the study. FWY003 is designed to block a protein in the immune system that causes inflammation. By blocking this protein, researchers think FWY003 could lessen inflammation and possibly slow the growth of GA lesions.
As part of the study, suitable participants will be screened to determine their eligibility for the trial. Eligible participants will be randomised to 1 of 2 groups: FWY003 treatment or placebo. You will have a 3 in 4 chance (75%) of receiving the active treatment FWY003. Both the study treatment and placebo is in the form of an oral capsule taken once daily.
The study duration is 22 months, with the frequency of visits being initially 1 to 2 months apart, before extending to every 3 months. For further information please contact Cerulea on 03 9929 8076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator
Professor Robyn Guymer
The purpose of this study is to learn about the effects and safety of a new potential treatment for people with geographic atrophy (GA) due to age-related macular degeneration (AMD). The potential new treatment is called FWY003.
To learn the effects of FWY003 on GA, researchers will measure the growth of the geographic atrophy area on images of the retina (eye) during the study. FWY003 is designed to block a protein in the immune system that causes inflammation. By blocking this protein, researchers think FWY003 could lessen inflammation and possibly slow the growth of GA lesions.
As part of the study, suitable participants will be screened to determine their eligibility for the trial. Eligible participants will be randomised to 1 of 2 groups: FWY003 treatment or placebo. You will have a 3 in 4 chance (75%) of receiving the active treatment FWY003. Both the study treatment and placebo is in the form of an oral capsule taken once daily.
The study duration is 22 months, with the frequency of visits being initially 1 to 2 months apart, before extending to every 3 months. For further information please contact Cerulea on 03 9929 8076 or info@ceruleaclinicaltrials.org.au
- Principal Investigator