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Sustained delivery of ranibizumab for AMD may reduce treatment burden

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SAN FRANCISCO — Sustained delivery of ranibizumab with a port delivery system in patients with neovascular age-related macular degeneration has the potential to improve visual outcomes and reduce the treatment burden associated with anti-VEGF injections, according to a scientific poster presented at the American Society of Retina Specialists meeting.

LADDER is a phase 2 study evaluating dosing and functional outcomes with sustained delivery of Lucentis (ranibizumab, Genentech) via the ranibizumab port delivery system (RPDS), which aims to provide longer treatment intervals than any currently available therapy, study co-author Richard F. Dreyer, MD, and colleagues said in the poster

LADDER is a multicenter, randomized, interventional, active-treatment controlled clinical trial projected to include 220 patients with neovascular age-related macular degeneration at up to 55 U.S. sites. Each patient will have the RPDS surgically implanted in the pars plana (subconjunctival). Primary endpoint for the study is the time to the first RPDS refill, according to the poster.

Patients will be randomized 3:3:3:2 to RPDS with one of three ranibizumab formulations or a monthly intravitreal injection of ranibizumab 0.5 mg. The secondary trial outcome will note the change from baseline in best corrected visual acuity, which will be used to test the non-inferiority for each of the RPDS patient groups vs. the intravitreal injection group.

The study follows a phase 1 single-center trial that established proof-of-concept and safety for the RPDS implant and sustained release of ranibizumab, according to the poster. – by Robert Linnehan

Reference:

Dreyer RF. Sustained delivery of ranibizumab: The LADDER trial of the ranibizumab port delivery system. Presented at: American Society of Retina Specialists 34th Annual Meeting, Aug. 9-14, 2016. San Francisco, Calif.

Disclosure: Dreyer reports he is an investigator for and receives grants from Genentech, Alcon and Regeneron.