Anecortave acetate as monotherapy for treatment of subfoveal neovascularization in age-related macular degeneration: twelve-month clinical outcomes☆
Section snippets
Materials and methods
Before patient enrollment, each participating clinical center obtained approval from its institutional review board or independent ethics committee. An institutional review board– or independent ethics committee–approved informed consent document was reviewed and signed by all potential study patients before the start of screening procedures. The principal investigator, subinvestigators, study coordinator(s), and support personnel at each clinical center were trained in specific study
Patient disposition
As demonstrated in Table 2, the 4 treatment groups were similar at baseline regarding numbers of patients, patient demographics, logMAR vision, and lesion characteristics. Clinical data from all patients were analyzed after completion of the 12-month study visit by the last study patient on April 30, 2002. Of the 128 patients enrolled and treated, 76 patients (59.4%) completed their month 12 visit. Patients were to be re-treated with their masked study medication if, in the masked
Discussion
The primary efficacy variable for this study was mean change from baseline in logMAR visual acuity. The 12-month data analysis demonstrates that anecortave acetate (15 mg) is safe and clinically efficacious compared with a placebo for both stabilization of vision (<3 logMAR line change) and inhibition of lesion growth. Statistically significant differences between anecortave acetate (15 mg) and the placebo were demonstrated for mean change from baseline logMAR vision, stabilization of vision,
Acknowledgements
The Writing Committee was responsible for preparation of the manuscript on behalf of the Anecortave Acetate Clinical Study Group. This Committee was composed of the following: Donald J. D'Amico, MD, Chairman, Independent Safety Committee; Morton F. Goldberg, MD, The Wilmer Eye Institute, Baltimore, MD, Consultant to Alcon Research, Ltd.; Henry Hudson, MD, Principal Investigator; Janice A. Jerdan, PhD, Alcon Research, Ltd.; D. Scott Krueger, PhD, Alcon Research, Ltd.; Susan P. Luna, MS, Alcon
References (18)
- et al.
Factors controlling ocular angiogenesis
Am J Ophthalmol
(1997) - et al.
New visual acuity charts for clinical research
Am J Ophthalmol
(1982) Parsing an enigmathe pharmacodynamics of aspirin resistance
Lancet
(2003)Epidemiology of age-related macular degeneration
Subfoveal neovascular lesions in age-related macular degenerationguidelines for evaluation and treatment in the Macular Photocoagulation Study
Arch Ophthalmol
(1991)Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfinone-year results of 2 randomized clinical trials—TAP Report
Arch Ophthalmol
(1999)Photodynamic therapy of subfoveal choroidal neovascularization in pathologic myopia with verteporfin1-year results of a randomized clinical trial—VIP Report No. 1
Ophthalmology
(2001)- et al.
A new pharmacological treatment for angiogenesis
- et al.
The effect of an angiostatic steroid on neovascularization in a rat model of retinopathy of prematurity
Invest Ophthalmol Vis Sci
(2001)
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Anterior Juxtascleral Delivery of Anecortave Acetate in Eyes with Primary Open-Angle Glaucoma: A Pilot Investigation
2009, American Journal of OphthalmologyTissue Repair and Regeneration
2008, Ocular TherapeuticsDrug Delivery Systems in Ophthalmic Applications
2008, Ocular TherapeuticsEvaluation of a calculation model to estimate the impact of the COVID-19 pandemic lockdown on visual acuity in neovascular AMD
2022, European Journal of Ophthalmology
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Manuscript no. 220690.
Financial support: grant research support, travel expenses, and honoraria.
Proprietary interest: none.
Portions of these data presented at: 2002 Retina Congress, October, 2002; San Francisco.
The 6-month results from this study have been published (Retina 2003;23:14–23).