Open label study of BI 754132 in patients with Geographic Atrophy.
Research type
Research Study
Full title
Safety, tolerability and pharmacokinetics of single rising intravitreal doses of BI 754132 in patients with geographic atrophy secondary to age-related macular degeneration (open label, non-randomized, uncontrolled).
IRAS ID
264426
Contact name
Chris Woods
Contact email
Sponsor organisation
Boehringer Ingelheim Ltd
Eudract number
2018-004125-92
Duration of Study in the UK
1 years, 1 months, 8 days
Research summary
This is a study to test how safe and how well different doses of BI 754132 are tolerated in patients with an advanced form of Age-related Macular Degeneration (AMD) called Geographic Atrophy (GA). This is the first time that BI 754132 will be given to humans and 18 participants are planned to take part globally, with up to 10 in the UK. It is planned to investigate up to 4 rising doses (3 participants per dose group in the first 3 groups; 6 participants in the last dose group; plus 3 additional participants as reserves) of BI 754132. Each participant will receive only one single injection of BI 754132 inside one eye, and the dose will be increased for subsequent dose groups unless problems concerning safety or tolerability are noted. The length of time each participant will last in the trial will be approximately 15 weeks and require 10 visits to the trial clinic. Participants will be required to undergo various blood tests, Opthalmological assessments, ECGs, physical examinations, as well as safety and medication monitoring throughout the trial. Participants are not expected to receive any benefit from participating in this trial but may contribute new information that could benefit other patients in future.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
19/SC/0253
Date of REC Opinion
18 Jun 2019
REC opinion
Further Information Favourable Opinion