A Study of the Efficacy, Safety, and Pharmacokinetics of a 36-Week Refill Regimen for the Port Delivery System With Ranibizumab in Patients With Neovascular Age-Related Macular Degeneration

VELODROME

Background

Neovascular age-related macular degeneration (nAMD), is a form of advanced AMD that causes rapid and severe visual loss, and remains a leading cause of visual impairment in the elderly. It is suspected that a growth factor known as “vascular endothelial growth factor (VEGF)” plays a role in the development and leakage of abnormal blood vessels. These abnormal blood vessels allow blood or fluid to leak into the macula and form scars, which cause a deterioration of central vision.

Ranibizumab is a medication that works by blocking the growth factor VEGF to slow the growth of abnormal blood vessels in the eye and the leakage of blood or fluid from these vessels, thereby helping to prevent or slow vision loss.

A key challenge with currently available anti-VEGF treatments is the requirement for frequent and long-term administration.

The Port Delivery System (PDS) is a refillable eye implant device that releases ranibizumab into the eye continuously over time. The PDS can remain in the eye long-term unless removed for health reasons.

Design

In Switzerland, the plan is to enroll approximately 20 participants across a total of 5 study centers. Worldwide, approximately 450 participants are expected to take part in the study across roughly 120 study centers in about 16 countries. The study will last approximately 3 years.

The purpose of this study is to evaluate the positive and negative effects of ranibizumab delivered by the PDS, in people with nAMD. It will be refilled either every 6 months or 9 months. Everyone in this clinical trial will have the PDS with ranibizumab surgically inserted into one eye under anaesthetic.