A Treat and Extend Regimen Using Ranibizumab for Neovascular Age-Related Macular Degeneration: Clinical and Economic Impact

• Published in: Ophthalmology (Rochester, Minn.) Vol. 117; no. 11; pp. 2134 - 2140
• Main Authors: GUPTA, Omesh P, SHIENBAUM, Gary, PATEL, Avni H, FECAROTTA, Christopher, KAISER, Richard S, REGILLO, Carl D
• Format: Journal Article
• Language: English
• Published: New York, NY Elsevier 01.11.2010
• Subjects: Aged; Aged, 80 and over; Antibodies, Monoclonal - administration & dosage; Antibodies, Monoclonal - economics; Antibodies, Monoclonal, Humanized; Biological and medical sciences; Choroidal Neovascularization - drug therapy; Choroidal Neovascularization - economics; Choroidal Neovascularization - physiopathology; Cost of Illness; Direct Service Costs - statistics & numerical data; Drug Costs; Female; Fluorescein Angiography; Humans; Injections; Macular Degeneration - drug therapy; Macular Degeneration - economics; Macular Degeneration - physiopathology; Male; Medical sciences; Middle Aged; Miscellaneous; Ophthalmology; Ranibizumab; Retinopathies; Retreatment; Retrospective Studies; Tomography, Optical Coherence; Visual Acuity - physiology; Vitreous Body; Immunomodulator; Eye disease; Retinopathy; Vascular endothelium growth factor; Treatment; Ranibizumab; Age related macular degeneration; Monoclonal antibody; Economic aspect; Neovascularization; Ophthalmology; Antiangiogenic agent
• ISSN: 0161-6420; 1549-4713
• DOI: 10.1016/j.ophtha.2010.02.032

To evaluate the visual outcome, number of injections, and direct medical cost of a "treat and extend" regimen (TER) in managing neovascular age-related macular degeneration (nAMD) with intravitreal ranibizumab. Retrospective, interventional, consecutive case series. Ninety-two eyes of 92 patients met the entry criteria from May 2006 to May 2008. All patients with treatment-naïve nAMD were treated monthly until no intraretinal or subretinal fluid was observed on optical coherence tomography (OCT). The treatment intervals were then sequentially lengthened by 2 weeks until signs of exudation recurred. The interval was individualized for each patient in an attempt to maintain an exudation-free macula. Change from baseline visual acuity, proportion of eyes losing < 3 lines and gaining ≥ 3 lines at 1 year of follow-up, annual mean number of injections, change from baseline OCT central retinal thickness (CRT), maximum period of extension, and adverse ocular and systemic events. The mean follow-up was 1.52 years. Mean Snellen visual acuity improved from 20/135 at baseline to 20/77 at 1 year follow-up (P < 0.001) and 20/83 at 2 years follow-up (P = 0.002). The proportion of eyes that lost < 3 Snellen visual acuity lines at final follow-up was 96% and the proportion that gained ≥ 3 Snellen visual acuity lines was 32%. The mean OCT CRT decreased from 303 μm at baseline to 238 μm at 1 year follow-up (P < 0.001). The mean number of injections over the first year and between years 1 and 2 was 8.36 and 7.45, respectively. The mean maximum period of extension was 79.9 days. No adverse ocular or systemic events were reported during the follow-up period. The direct annual medical cost per patient was $16,114.52 for the TER. The direct annual medical cost per patient ranged from $15,880.07 to $28,314.16 based on previous clinical trial protocols. Eyes with nAMD experienced significant visual improvement when managed with intravitreal ranibizumab using a TER. This treatment approach also was associated with significantly fewer patient visits, injections, and direct annual medical cost compared with monthly injections such as in the phase III clinical trials. Proprietary or commercial disclosure may be found after the references.