HARRIER: Clinical trial on patients with choroidal neovascularisation secondary to AMD 21/09/2015
This Phase III trial assesses the efficacy and safety of RTH258 6mg administered through intravitreal injections in patients with choroidal neovascularisation secondary to Age-Related Macular Degeneration (AMD) in comparison to the administration of aflibercept (EYLEA®). This is a double-blind, randomised, multicentric trial assessing a 6mg dose of RTH258 administered on a monthly basis over the first three visits and then every 12 months through intravitreal injections compared to a dose of aflibercept 2mg (EYLEA®) injected monthly over the first three visits followed by injections every eight weeks.
This trial will be conducted over a two-year period.
Key inclusion criteria
Patients are above 50 years old with choroidal neovascularisation secondary to Age-Related Macular Degeneration (AMD) in the study eye. They have not previously received treatment for the disease.
The primary aim is to demonstrate that RTH258 administered every 12 weeks is not inferior to aflibercept 2mg injected every eight weeks. This criterion will be assessed through the change in the patient’s vision after 48 weeks.
The secondary aims are focused on the assessment of the efficacy of RTH258 6mg compared to aflibercept 2mg through the assessment of the patient’s vision, anatomical parameters and the need to shorten the treatment interval.
Clinical studies have demonstrated RTH258 to be as effective as ranibizumab and aflibercept in the improvement in vision results despite a lower treatment frequency. It therefore will provide a potential benefit to subjects and their carers or doctors.
If you are interested in taking part in a clinical trial, please call us at +34 93 595 01 55 and we will assess whether you are eligible.
Dr. Jordi Monés, M.D., Ph.D.
COMB Medical license number: 22.838
Doctor of Medicine and Surgery
Specialist in Ophthalmology
Specialist in Retina, Macula and Vitreorretinal