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The 2-year results of the PrONTO Study indicated that intravitreal injections of ranibizumab (Lucentis, Genentech) produces rapid improvements in visual acuity (VA) and optical coherence tomography (OCT) outcomes in patients treated for neovascular age-related macular degeneration. The changes on OCT are visible before the changes in VA and allow ophthalmologists to determine each patient's need for additional dosing of ranibizumab.
Miami-The 2-year results of the PrONTO Study indicated that intravitreal injection of ranibizumab (Lucentis, Genentech) produces rapid improvements in visual acuity (VA) and optical coherence tomography (OCT) outcomes in patients treated for neovascular age-related macular degeneration (AMD), said Philip Rosenfeld, MD, PhD.
The goal of the PrONTO Study was to determine if OCT could be used to assess the need for re-treatment once the fluid in the macula was eliminated. After an induction regimen of three intravitreal injections of ranibizumab, the need for additional intravitreal injections was based on the appearance of the macula using OCT.
Dr. Rosenfeld explained that the major inclusion criteria were macular neovascularization of any angiographic type that involved the fovea as long as the central retinal thickness was a minimum of 300 μm and VA that was in the range of 20/40 to 20/400.
After the three monthly injections, patients could undergo additional injections if the investigators identified changes from the previous evaluation, specifically, a loss of five letters or more of VA associated with macular fluid observable on OCT images, if the central retinal thickness measured by OCT increased by 100 μm or more, if there were new hemorrhages or new classic choroidal neovascularization, or if neovascularization persisted in the macula 1 month following an injection.
Based on the evidence collected during the first year of the study, the strict re-treatment criteria were relaxed in the second year of the study and replaced with the requirement that any qualitative change by OCT consistent with new or persistent fluid in the macula was sufficient to trigger a re-treatment.