Original articleA Variable-dosing Regimen with Intravitreal Ranibizumab for Neovascular Age-related Macular Degeneration: Year 2 of the PrONTO Study
Section snippets
Methods
PrONTO was a 2-year, open-label, prospective, single-center clinical study designed to investigate the efficacy, durability, and safety of a variable-dosing regimen with intravitreal ranibizumab in patients with neovascular AMD. The PrONTO Study was an investigator-sponsored trial supported by Genentech Inc and performed after review by the Food and Drug Administration (FDA). Informed consent was obtained from all patients before determination of full eligibility.
The major efficacy endpoints
Study Compliance
Patient demographics and enrollment at baseline were described previously.7 Between August 23, 2004 and April 25, 2005, a total of 69 patients were screened for the study and 40 patients were enrolled. At baseline, the mean and median VA letter scores were 56 (20/80+1) and 57 (20/80+2), respectively (Table 3). Baseline mean and median OCT 1-mm CRT measurements were 394 and 385 μm, respectively (Table 4). The characteristics of the neovascular lesions were described previously. Of note, the
Discussion
In the PrONTO Study, intravitreal injections of ranibizumab were shown to improve VA and rapidly to reduce the amount of macular fluid in most patients with neovascular AMD. This decrease in retinal thickness, which was detectable within 1 day after the first injection, continued through the first 3 months and was maintained through 24 months using an OCT-guided variable-dosing regimen. During the first year, strict quantitative retreatment guidelines were followed. These guidelines were
Geeta A. Lalwani, MD, graduated with honors in Chemistry and East Asian Studies from Smith College in 1994 and received her MD from MCP-Hahnemann School of Medicine in 2001, where she was elected into the Alpha Omega Alpha honor society. Dr Lalwani completed her ophthalmology residency at Case Western University and a subsequent fellowship in vitreoretinal surgery at the Bascom Palmer Eye Institute in Miami, Florida. In 2007, she joined the faculty at the Bascom Palmer Eye Institute where she
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Geeta A. Lalwani, MD, graduated with honors in Chemistry and East Asian Studies from Smith College in 1994 and received her MD from MCP-Hahnemann School of Medicine in 2001, where she was elected into the Alpha Omega Alpha honor society. Dr Lalwani completed her ophthalmology residency at Case Western University and a subsequent fellowship in vitreoretinal surgery at the Bascom Palmer Eye Institute in Miami, Florida. In 2007, she joined the faculty at the Bascom Palmer Eye Institute where she continues clinical research in numerous areas.
See accompanying Editorial on page 1.
Anne Fung is currently at the Pacific Eye Associates, California Pacific Medical Center, San Francisco, California. Stephen Michels is currently at the Department of Ophthalmology, University Hospital Zürich, Zürich, Switzerland.