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Clinical Trials in AMD
Age-Related Macular Degeneration Studies
Age-related macular degeneration (AMD) is the leading cause of irreversible vision impairment in older adults. The prevalence of advanced AMD increases with each decade after age 50 years, with the highest prevalence found among those age >80 years. AMD affects upwards of 50 million people worldwide. [Roh.Yanoff Ophthalmology.2019]
There are two forms of AMD: neovascular (wet) and non-neovascular (dry). Although there is no cure for either type, vitamins, good nutrition, and smoking cessation can slow dry AMD progression; AREDS was the first study to demonstrate the benefit of antioxidant and zinc supplementation on the progression of AMD and the associated vision loss. [Roh.Yanoff.Ophthalmology.2019]
Wet AMD was originally treated with lasers and then photodynamic therapy with verteporfin until anti-vascular growth factor (anti-VEGF) injections were found to be more efficacious than laser treatment. Currently, the standard of care for the treatment of wet AMD is aflibercept and ranibizumab, although off-label bevacizumab is often used as well. Pegaptanib sodium (Macugen®) was the first anti-VEGF treatment approved for wet AMD, but is rarely used in today’s clinical settings. [Roh.Yanoff.Ophthalmology.2019]
An ongoing debate in the treatment of wet AMD is the dosing regimen for anti-VEGF therapy. In this disease, effective anti-VEGF treatment necessitates monthly dosing, which can lead to a significant treatment burden for patients, caretakers, and treating physicians. [Roh.Yanoff.Ophthalmology.2019] To overcome those burdens, alternative dosing strategies have been studied, included as-needed treatment (PRN) and treat-and-extend (T&E) therapy. [Roh.Yanoff.Ophthalmology.2019] There are also approved drugs with longer duration of treatment intervals, namely brolucizumab, and others are under investigation. This section lists the most relevant clinical studies in AMD.
Click on the study name to see more details about each particular study. To enhance visibility of graphs and tables, click on the image to enlarge for expanding viewing.
Studies in Dry AMD
References
Abraham P, Yue H, Wilson L. Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2. Am J Ophthalmol. 2010;150:315-324.e1.
Age-Related Eye Disease Study Research Group. The Age-Related Eye Disease Study (AREDS): Design implications AREDS report no.1. Control Clin Trials. 1999;20:573-600.
Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001;119:1417-1436.
Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013;309:2005-2015.
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Holekamp NM, Campochiaro PA, Chang MA, et al. Archway randomized phase 3 trial of the port delivery system with ranibizumab for neovascular age-related macular degeneration. Ophthalmology. 2021;S0161-6420(21)00734-X. Online ahead of print. doi:10.1016/j.ophtha.2021.09.016
Holz FG, Minnella AM, Tuli R, Yoganathan P, Parikh S, Hamilton R; LUMINOUS study group. Ranibizumab treatment patterns in prior ranibizumab-treated neovascular age-related macular degeneration patients: Real-world outcomes from the LUMINOUS study. PLoS One. 2020;30;15(12):e0244183. doi:10.1371/journal.pone.0244183
Holz FG, Sadda SR, Busbee B, et al. Efficacy and safety of lampalizumab for geographic atrophy due to age-related macular degeneration: Chroma and Spectri phase 3 randomized clinical trials. JAMA Ophthalmol. 2018;136:666-677.
Holz FG, Tadayoni R, Beatty S, et al. Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration. Br J Ophthalmol. 2015;99:220-226.
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NCT03525613. A Study to Compare the Efficacy and Safety of Intravitreal APL-2 Therapy With Sham Injections in Patients With Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration. Last update September 16, 2020. Accessed February 10, 2021. https://clinicaltrials.gov/ct2/show/NCT03525613
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