On Demand Lucentis as Effective as Monthly Injections – Two-Year PRONTO Study

May 2, 2009

Irv Arons

According to two-year results of the PRONTO study due for publication in the American Journal of Ophthalmology, Novartis’ Lucentis (ranibizumab) administered on demand is as effective as monthly injections for neovascular age related macular degeneration (AMD), with fewer injections required.

This is the first study to show the efficacy of “on demand” treatment, depending on the results of optical coherence tomography (OCT), while Phase III studies concentrated on a regimen of monthly injections.

Dr Greeta Lalwani of Miami’s Bascom Palmer Eye Institute and colleagues report the results of this open-label prospective study in 40 patients. The patients received a monthly intravitreal injection (0.5 mg) of ranibizumab for three months. After the first three months, the need for re-treatment was evaluated during the monthly check-up visit and depended on results. Re-treatment occurred when central retinal thickness had increased by at least 100 ?m as shown by OCT, or when the patient had ‘lost’ at least five letters.

During the second year, re-treatment criteria were altered to allow re-treatment where the volume of liquid revealed by OCT had increased. Of the 40 patients, 37 completed the two-year study. Average visual acuity improved by 11.1 letters and retinal thickness decreased by 212 ?m. Visual acuity improved by at least 15 letters in 43% of patients.

These results were obtained with an average of 9.9 injections over 24 months.

The researchers conclude that “using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in visual acuity outcomes comparable with the outcomes from the Phase III clinical studies, but fewer intravitreal injections were required”.