Stereotactic Radiotherapy Reduces Anti-VEGF Injections by 3.2 Over 4 Years in Chronic Wet AMD, But Worsens Visual Acuity

Neovascular age-related macular degeneration (nAMD), also known as wet AMD, is a leading cause of irreversible vision loss due to abnormal blood vessel growth (choroidal neovascularization). Current standard-of-care involves frequent intravitreal injections of anti-VEGF agents, which are highly effective but impose a significant treatment burden on patients and healthcare systems. The need for less frequent, yet effective, treatment options remains a critical unmet need, prompting investigation into adjunctive therapies like stereotactic radiotherapy to potentially reduce injection frequency and improve patient quality of life.

This randomized, double-masked, sham-controlled device trial (STAR) enrolled 411 participants aged at least 50 years with chronic, pretreated, active nAMD. Participants received a one-off 16 Gray stereotactic radiotherapy (SRT) or sham SRT delivered via a robotically controlled device. After two years of monthly study visits, participants reverted to routine care, with masking maintained. Repeat data collection occurred at years 3 and 4. Primary efficacy outcomes at year 4 were anti-VEGF injections (tested for superiority) and visual acuity (tested for non-inferiority with a five-letter margin).