X-82 in Age-Related Macular Degeneration
Research type
Research Study
Full title
A randomized, double-masked, placebo-controlled, dose-finding, non-inferiority study of X-82 plus prn Eylea compared to prn Eylea monotherapy in neovascular AMD
IRAS ID
140280
Contact name
Timothy Jackson
Contact email
Sponsor organisation
Doccla AB
Eudract number
2015-001632-38
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT02348359, Clin Trials . Gov Ref No.
Duration of Study in the UK
1 years, 10 months, 22 days
Research summary
X-82 is a tablet that when swallowed gets in to the blood stream and prevents the growth of blood vessels that allow tumours to grow and it also stops the growth of abnormal blood vessels in the eye that lead to the vision loss in wet AMD patients.
X-82 has been tested in 35 patients with wet AMD who received the drug at doses ranging from 50 mg every other day to 300 mg per day for up to 24 weeks. All of these patients’ vision remained the same or improved while they took X-82 and most of them (70%) did not need any injections for their vision while they were taking X-82. The fluid in the eyes of many of these patients went away while they were receiving X-82.
This phase 2 study now proposes to investigate further the safety and efficacy of three doses (50, 100 and 200 mg qd) compared to placebo in a randomized double-masked study in which patients will be treated for 1 year.
REC name
London - City & East Research Ethics Committee
REC reference
15/LO/1089
Date of REC Opinion
23 Sep 2015
REC opinion
Further Information Favourable Opinion