Stereotactic Radiotherapy for Wet AMD (STAR)

Summary

This study investigates the use of radiation to treat wet age-related macular degeneration (AMD). The radiation is delivered using a robotically controlled device that projects overlapping beams of radiation onto the macula, the part of the eye that is affected by wet AMD. Participants will be randomized to receive radiation (stereotactic radiotherapy) or simulated placebo treatment (sham control). They will be followed up regularly for two years, and then again at the end of three and four years for a safety visit. Participants will also receive injections of ranibizumab (Lucentis) into their eye if their wet AMD is active. Ranibizumab is the standard anti-VEGF agent that is used to treat wet AMD. The study aims to determine if stereotactic radiosurgery can maintain vision and reduce the need for such regular anti-VEGF injections.

Timeline

Start

2014-12

Primary completion

2021-12

Completion

2024-04

Publications

• Jackson TL, Desai R, Wafa HA, Lee CN, Wang Y, Peacock JL, Peto T, Chakravarthy U, Zhu X, Dakin H, Wordsworth S, Clinch P, Ramazzotto L, Neffendorf JE, O'Sullivan JM, Reeves BC; STAR study group. 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). BMJ. 2026 Jun 18;393:e729694. doi: 10.1136/bmj-2026-729694.
• Jackson TL, Desai R, Wafa HA, Wang Y, Peacock J, Peto T, Chakravarthy U, Dakin H, Wordsworth S, Lewis C, Clinch P, Ramazzotto L, Neffendorf JE, Lee CN, O'Sullivan JM, Reeves BC; STAR study group. Stereotactic radiotherapy for neovascular age-related macular degeneration (STAR): a pivotal, randomised, double-masked, sham-controlled device trial. Lancet. 2024 Jul 6;404(10447):44-54. doi: 10.1016/S0140-6736(24)00687-1. Epub 2024 Jun 11.
• Neffendorf JE, Desai R, Wang Y, Kelly J, Murphy C, Reeves BC, Chakravarthy U, Wordsworth S, Lewis C, Peacock J, Uddin S, O'Sullivan JM, Jackson TL. StereoTactic radiotherapy for wet Age-Related macular degeneration (STAR): study protocol for a randomised controlled clinical trial. Trials. 2016 Nov 24;17(1):560. doi: 10.1186/s13063-016-1676-7.

Drugs

Indications