Light Touch Study
Research type
Research Study
Full title
A Multicentre Randomised Controlled Clinical Trial testing the non-inferiority of a lighter to the standard initial dosing regimen of Faricimab in Patients with Pretreated Neovascular Age-Related Macular Degeneration.
IRAS ID
1010355
Contact name
Sobha Sivaprasad
Contact email
Sponsor organisation
Moorfields Eye Hospital
ISRCTN Number
ISRCTN10012824
Research summary
The Light Touch study looks at patients with neovascular Age-Related Macular Degeneration that have been receiving regular intravitreal injections and would be eligible to switch to a new agent - faricimab. The usual approach to switching would require an initial 4 injections over 4 months. This study looks at whether starting treatment with fewer drug injections (i.e., a "Light touch') can still help patients see well, aiming to make treatment less demanding by reducing the number of doctor visits and injections needed.
Study Design: The study is a Phase III, multicentre, prospective, controlled, non-inferiority clinical trial. It will compare two treatment regimens of Faricimab: the standard induction phase (four initial monthly injections) versus a "light touch" regimen (one initial injection followed by personalized treatment intervals).
Sites and Duration: The study will be conducted across ophthalmology centers in England. The total study period is 112 weeks, including a 56-week treatment and follow-up phase for participants.Funding and Support: The study is funded by Roche Products Limited and sponsored by Moorfields Eye Hospital NHS Foundation Trust.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
24/SC/0237
Date of REC Opinion
9 Sep 2024
REC opinion
Further Information Favourable Opinion