Stereotactic radiotherapy for neovascular age related macular degeneration: year 3 and 4 extended follow up results of a randomised, double masked, sham controlled, device trial (STAR)
In brief
Stereotactic radiotherapy worsens vision by about eight letters despite modest injection reduction
In the STAR trial, a single 16 Gy stereotactic radiation dose cut the average number of anti-VEGF injections by roughly three over four years, but patients lost about eight letters of visual acuity compared with sham treatment. Safety was similar, yet the vision loss overturns earlier benefits, so SRT cannot be recommended for neovascular AMD.
- Journal
- BMJ (Q1)
- Published
- 18 June 2026
- Study design
- Randomized controlled trial
- Evidence level
- Level 1, High (CEBM 1b)
- Authors
- Timothy L Jackson, Riti Desai, Hatem A Wafa, Chan Ning Lee, Yanzhong Wang, Janet L Peacock, et al.
- PMID
- 42315290
- DOI
- 10.1136/bmj-2026-729694
Why clinicians should know about it
- Picked for Ophthalmology (top studies of the week, 25 October 2026): Randomized trial of radiotherapy and anti-VEGF treatment burden in neovascular
Abstract
OBJECTIVE: To assess the effects of stereotactic radiotherapy (SRT) for neovascular age related macular degeneration (AMD) beyond the two year primary outcome of the StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR) trial. DESIGN: Randomised, double masked, sham controlled, device trial involving preplanned recall from standard care. SETTING: 30 NHS hospitals in the UK. PARTICIPANTS: 411 participants aged at least 50 years with chronic, pretreated, active AMD. INTERVENTION: Participants received one-off 16 Gray SRT or sham SRT delivered using a robotically controlled device. After two years of monthly study visits, participants reverted to routine care, with anti-VEGF drug selection and dosing intervals based on local practice, but with masking maintained, and repeat data collection at years 3 and 4 study visits. MAIN OUTCOME MEASURES: The main efficacy outcome at year 4 was the number of anti-VEGF injections, tested for superiority (fewer injections). The other main outcome was visual acuity, tested for non-inferiority (five letter margin). Safety outcomes included adverse events, serious adverse events, and microvascular abnormalities. The same analyses were undertaken at years 2, 3, and 4. A within trial costing analysis was undertaken for participants with four years' follow-up. RESULTS: Of 411 participants (204 (58%) women), 274 were allocated to SRT and 137 to sham SRT. The year 4 intention-to-treat efficacy analysis included 222 (81%) participants in the SRT group and 106 (77%) in the sham SRT group. The SRT group received a mean of 19.1 (standard deviation 10.9) injections over four years versus 21.6 (11.3) with sham SRT, an adjusted decrease of 3.2 injections (95% confidence interval (CI) of difference -5.7 to -0.7). During years 3 and 4, the SRT group received a mean cumulative 8.4 injections versus 8.3 injections in the sham SRT group. The final change in visual acuity in the SRT group was 8.3 letters worse than in the sham group (95% CI of difference -12.7 to -4.0). Adverse event rates were similar between groups, but reading centre-detected microvascular abnormalities occurred in 126/218 SRT treated eyes (58%) and 16/102 (16%) sham SRT treated eyes. CONCLUSION: Although the overall reduction in intravitreal therapy was maintained to year 4, the inferior vision in SRT treated eyes effectively reversed the conclusions of the year 2 primary outcome analysis and no longer supports the use of SRT to treat neovascular AMD. Including standard care, masked, extended follow-up within a clinical trial may provide useful clinical insight. TRIAL REGISTRATION: ClinicalTrials.gov NCT02243878.
Abstract as published, via PubMed.
For healthcare professionals. The summary is generated by AI from the published abstract, and the evidence level is assigned automatically from the study design on the Oxford CEBM hierarchy. Neither is medical advice. Read the full paper before changing practice.