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 has been discontinued. [Roh.Yanoff Ophthalmology.2019] [Almony. AJMC 2023]
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. [Almony. AJMC 2023] To overcome those burdens, alternative dosing strategies have been studied, included as-needed treatment (PRN) and treat-and-extend (T&E) therapy. [Almony. AJMC 2023]There are also approved drugs with longer duration of treatment intervals, such as aflibercept 8 mg, faricimab, and the ranibizumab port delivery system, with other therapies under investigation. [Almony. AJMC 2023] 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
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- A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA). Clinicaltrials.gov identifier: NCT03823287. Last updated February 16, 2023. https://clinicaltrials.gov/study/NCT03823287
- A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE). Clinicaltrials.gov identifier: NCT03823300. Last updated January 13, 2023. https://clinicaltrials.gov/study/NCT03823300
- Almony A. Treatment approaches for neovascular age-related macular degeneration and diabetic macular edema. Am J Manag Care. 2023;29(6 suppl):S81-S89. https://www.ajmc.com/view/treatment-approaches-for-neovascular-age-related-macular-degeneration-and-diabetic-macular-edema
- Cheung CMG, Lim JI, Priglinger S, et al. Anatomic Outcomes with Faricimab vs Aflibercept in Head-to-Head Dosing Phase of the TENAYA/LUCERNE Trials in Neovascular Age-related Macular Degeneration. Ophthalmology. Published online November 30, 2024. https://www.aaojournal.org/article/S0161-6420(24)00748-6/fulltext
- Galeone C, Turati F, Nicolò M, et al. Faricimab versus the standard of care for neovascular age-related macular degeneration in Italy: An indirect treatment comparison. Drug Target Insights. 2024;18:105-111. https://journals.aboutscience.eu/index.php/dti/article/view/3213
- Khanani AM, Kotecha A, Chang A, et al. TENAYA and LUCERNE: Two-year results from the phase 3 neovascular age-related macular degeneration trials of faricimab with treat-and-extend dosing in year 2. Ophthalmology. 2024;131:914-926. https://www.aaojournal.org/article/S0161-6420(24)00134-9/fulltext
- Parravano M, Viola F, Nicolò M, et al. Real-world evidence of anti-VEGF therapies in patients with neovascular age-related macular degeneration in Italy: The RADIANCE study. Eur J Ophthalmol. Published online February 3, 2025. https://journals.sagepub.com/doi/10.1177/11206721241310628
- Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration. Clinicaltrials.gov identifier: NCT04423718. Last updated September 19, 2024. https://clinicaltrials.gov/study/NCT04423718
- Roh, M, Kim IK. Age-related macular degeneration. In: Yanoff M, ed. Ophthalmology. 5th ed. Elsevier; 2019(6.29):586-602.e3.
- Wong T. Aflibercept 8 mg in neovascular age-related macular degeneration: 156-week results from the PULSAR extension. Presented at: Macula Society 2025; February 15, 2025; Charlotte Harbour, FL. https://regeneronmedical.com/view-content?id=a1bPr000002XhmjIAC&type=Publications&disease=AMD&ta=Ophthalmology&congress=The%20Macula%20Society%202025
All URLs accessed April 11, 2025
