| 1 |
Clinical Conference A variable-dosing regimen with intravitreal ranibizumab for neovascular age-related macular degeneration: year 2 of the PrONTO Study. 2009
Lalwani GA, Rosenfeld PJ, Fung AE, Dubovy SR, Michels S, Feuer W, Davis JL, Flynn HW, Esquiabro M. · Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida 33136, USA. · Am J Ophthalmol. · Pubmed #19376495 No free full text.
Abstract: PURPOSE: To assess the long-term efficacy of a variable-dosing regimen with ranibizumab in the Prospective Optical Coherence Tomography (OCT) Imaging of Patients with Neovascular Age-Related Macular Degeneration (AMD) Treated with intraOcular Ranibizumab (PrONTO) Study, patients were followed for 2 years. DESIGN: A 2-year prospective, uncontrolled, variable-dosing regimen with intravitreal ranibizumab based on OCT. METHODS: In this open-label, prospective, single-center, uncontrolled clinical study, AMD patients with neovascularization involving the central fovea and a central retinal thickness (CRT) of at least 300 microm as measured by OCT were enrolled to receive 3 consecutive monthly intravitreal injections of ranibizumab (0.5 mg) [Lucentis; Genentech Inc, South San Francisco, California, USA]. During the first year, retreatment with ranibizumab was performed at each monthly visit if any criterion was fulfilled such as an increase in OCT-CRT of at least 100 microm or a loss of 5 letters or more. During the second year, the retreatment criteria were amended to include retreatment if any qualitative increase in the amount of fluid was detected using OCT. RESULTS: Forty patients were enrolled and 37 completed the 2-year study. At month 24, the mean visual acuity (VA) improved by 11.1 letters (P < .001) and the OCT-CRT decreased by 212 microm (P < .001). VA improved by 15 letters or more in 43% of patients. These VA and OCT outcomes were achieved with an average of 9.9 injections over 24 months. CONCLUSIONS: The PrONTO Study using an OCT-guided variable-dosing regimen with intravitreal ranibizumab resulted in VA outcomes comparable with the outcomes from the phase III clinical studies, but fewer intravitreal injections were required.
|
| 2 |
Article Long-term safety and efficacy of intravitreal bevacizumab (Avastin) for the management of central retinal vein occlusion. 2008
Gregori NZ, Gaitan J, Rosenfeld PJ, Puliafito CA, Feuer W, Flynn HW, Berrocal AM, Al-Attar L, Dubovy S, Smiddy WE, Schwartz SG, Lee WH, Murray TG. · Department of Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, 900 NW 17th St., Miami, FL 33136, USA. · Retina. · Pubmed #19430392 No free full text.
Abstract: PURPOSE: To evaluate the long-term safety and efficacy of intravitreal bevacizumab injections (Avastin, Genentech Inc., San Francisco, CA) for the treatment of macular edema secondary to central retinal vein occlusions. METHODS: A retrospective review was performed of eyes treated from May 2005 to August 2006 with follow-up through February 2007. The dose of bevacizumab was 1.25 mg (0.05 mL). Retreatment was performed at monthly or longer intervals at the discretion of the treating physician. RESULTS: Fifty-seven eyes received intravitreal bevacizumab at baseline. Visual acuity improved by a mean of 14 letters (N = 53; P < 0.001) at 1 month, 13 letters at 3 months (N = 53; P < 0.001), 9 letters at 6 months (N = 30; P = 0.001), 9 letters at 12 months (N = 17; P = 0.004). The mean optical coherence tomography thickness decreased by 299 microm at 1 month (N = 53; P < 0.001), 144 microm at 3 months, (N = 53; P < 0.001), 127 microm at 6 months (N = 30; P = 0.011), and 276 microm at 12 months (N = 17; P < 0.001). No ocular or systemic adverse events were observed. CONCLUSION: Improvements in visual acuity and optical coherence tomography were observed during the first year following intravitreal bevacizumab for macular edema secondary to central retinal vein occlusions. These retrospective results provide additional evidence to support the perceived safety and efficacy of intravitreal bevacizumab in this disorder.
|
|
|