Active comparator-controlled study of KSI-301 in patients with Wet AMD
Research type
Research Study
Full title
A Phase 2, Prospective, Randomized, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects with Neovascular (Wet) Age-related Macular Degeneration
IRAS ID
269452
Contact name
Andrew Lotery
Contact email
Sponsor organisation
Kodiak Sciences Inc.
Eudract number
2018-003428-35
Duration of Study in the UK
2 years, 6 months, 27 days
Research summary
This is a comparator-controlled, double-blinded Phase 2 study to see how safe and effective the experimental drug KSI-301 is when given by an injection into the eye for patients with Wet Age-related Macular Degeneration (AMD) over a 92-week period.
Wet AMD is a progressive disease affecting a central part of the eye responsible for seeing fine details, and perceiving colour. A common eye condition caused by abnormal blood vessel growth and leakage, wet AMD affects people aged over 50 and is one of the most common causes of blindness in developed countries. As the world’s population continues to both grow and age, an increasing number of people will be affected by wet AMD.
There are also concerns about current treatments for wet AMD, particularly the durability of treatments and the burden of monthly clinic visits, which is a significant issue for the ageing treatment population. There is a substantial medical need to find longer-lasting therapeutic options that could reduce the high treatment burden for patients with wet AMD.KSI-301, the study drug, blocks a molecule called VEGF, which is involved in blood vessel development. Inappropriate VEGF activity plays an important role in the development of wet AMD. KSI-301 does not need to be administered as frequently as standard treatments, so this study aims to test whether KSI-301 is as effective as these options. A recent Phase 1 study has identified no significant safety risks to date.
Approximately 368 patients with wet AMD will be enrolled during the trial, half of which will be randomised to receive the standard treatment for this condition (aflibercept), and the other half KSI-301. Study assessments will include blood and urine sampling, vital signs, assessment of visual acuity, ophthalmic exams, post-injection assessments, imaging and photography of the eye, as well as monitoring of adverse events and existing treatments.
REC name
South Central - Hampshire A Research Ethics Committee
REC reference
19/SC/0402
Date of REC Opinion
2 Sep 2019
REC opinion
Favourable Opinion