One Year Results of the PrONTO Study:
An OCT-Guided Variable-Dosing Regimen with
Ranibizumab (Lucentis™) In Neovascular AMD
Anne Fung¹, Philip J. Rosenfeld², Carmen Puliafito², Stephan Michels³, Geeta A. Lalwani², William J. Feuer² (¹San Francisco, ²Miami, ³Vienna)

Purpose: In the Phase III trials, ranibizumab (Lucentis™, Genentech) was injected every month for 2 years to treat neovascular AMD patients. These monthly intravitreal injections resulted in
an improvement in mean visual acuity (VA) at 1 year in both Phase III trials. These VA results were similar to the earlier results obtained in the Phase I/II studies following monthly injections for 5 months or 7 months. Once these monthly injections were stopped at the end of the Phase I/II studies, we were able to follow these patients in an extension study. At the Bascom Palmer Eye Institute, we maintained the improved VA in these patients for at least 2 years by using a less frequent OCT-guided variable dosing regimen. To test this variable dosing regimen, we initiated a single-site, FDA-reviewed, investigator sponsored trial known as the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Lucentis (PrONTO) Study.
Methods: Neovascular AMD patients with VA from 20/40 to 20/400 and OCT central retinal thickness measurements of at least 300 mm were enrolled. Each patient received 3 consecutive monthly injections of ranibizumab (500 mg) in their study eye given at baseline, Month 1, and Month 2. OCT measurements were obtained at baseline and on post-injection days 1, 2, 4, 7, 14, and 30 during the first 2 months then monthly thereafter. EDTRS visual acuities were obtained at baseline and on post-injection days 14, 30, 45, 60 and then monthly thereafter. Fluorescein angiography was performed at baseline and every 3 months. Retreatment with ranibizumab was performed only if one of the following occurred: an increase in central OCT thickness of at least 100 mm, a loss of 5 letters in conjunction with recurrent fluid detected by OCT, new onset classic neovascularization, or new macular hemorrhage.
Results: Forty patients were enrolled. By Month 3, 1 month after the last scheduled injection, the mean VA score improved by 10 letters (p<0.001) and the mean central thickness measurement decreased by 190 mm (p<0.001). By Month 7, 5 months after the last scheduled injection, the average number of retreatments per eye was 0.2 with 50% of eyes receiving no additional treatment. The mean VA improved by 9 letters (p<0.001) and the mean central thickness measurement decreased by 158 microns (p<0.001) compared with baseline. No drug-related adverse events were observed.
Conclusion: The improvements in VA and OCT measurements observed by Month 3 were maintained through Month 7 using an OCT-guided variable dosing regimen. These visual acuity results are very similar to the results observed in the Phase III trials at 7 months. One year results will be discussed. Continued follow-up is planned through 2 years.

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