Stereotactic Radiotherapy for Wet AMD (STAR)
STAR
StereoTactic Radiotherapy for Wet Age-Related Macular Degeneration (STAR): A Randomised, Double-masked, Sham-controlled, Clinical Trial Comparing Low-voltage X-ray Irradiation With as Needed Ranibizumab, to as Needed Ranibizumab Monotherapy.
3 other identifiers
interventional
411
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2014
Longer than P75 for phase_3
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 8, 2014
CompletedFirst Posted
Study publicly available on registry
September 18, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2024
CompletedAugust 6, 2025
August 1, 2025
7 years
September 8, 2014
August 1, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Number of as required (prn) ranibizumab injections during the first 24 months
Monitor the number of eye injections
24 months
Secondary Outcomes (1)
Mean Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity (VA) at 24 months.
24 months
Study Arms (2)
Arm A (treatment)
EXPERIMENTALParticipants will receive Stereotactic radiotherapy, a 16 Gy dose of radiation, delivered to the macula. Participants will receive intravitreal injections of 0.5 mg ranibizumab at baseline, and then administered 'as required' (PRN) up to monthly, if predefined retreatment criteria are met.
Arm B (control)
SHAM COMPARATORParticipants will receive a sham treatment. Participants will receive intravitreal injections of 0.5 mg ranibizumab at baseline, and then administered 'as required' (PRN) up to monthly, if predefined retreatment criteria are met.
Interventions
Participants will be allocated in a 2:1 ratio to either 16 Gray SRT (IRay, Oraya, Newark,USA) delivered in a single session, or sham SRT.
Both arms will receive intravitreal injections of 0.5 mg ranibizumab at baseline, and then administered 'as required' (PRN) up to monthly, if predefined retreatment criteria are met.
Eligibility Criteria
You may qualify if:
- Participants must have neovascular AMD in the study eye, for which they have received at least 3 prior intravitreal injections of either bevacizumab (Avastin), aflibercept (Eylea), ranibizumab (Lucentis), or pegaptanib (Macugen).
- Participants must have received an anti-VEGF injection in the study eye within 3 months prior to enrolment.
- Participants must require treatment with anti-VEGF therapy at the time of enrolment, due to OCT evidence of subretinal fluid and/or cystoid macular oedema, and have a macular volume that is greater than the 95th percentile of normal for the SD-OCT machines used in the investigational sites.
- Participants must be at least 50 years of age.
You may not qualify if:
- Disciform scarring that involves the fovea, in the study eye.
- Visual acuity worse than 6/96 (24 ETDRS letters) in the study eye.
- Lesion size greater than 4 mm in greatest linear dimension, or greater than 2 mm from the centre of the fovea to the furthest point on the lesion perimeter.
- An axial length of less than 20 mm, or greater than 26 mm, in the study eye.
- Contraindication or sensitivity to contact lens application, including recurrent corneal erosions, in the study eye.
- Type 1 or Type 2 diabetes mellitus.
- Retinopathy in the study eye.
- Prior or current therapies in the study eye for age-related macular degeneration, other than anti-VEGF agents, including submacular surgery, subfoveal thermal laser photocoagulation, photodynamic therapy (PDT), or transpupillary thermotherapy (TTT).
- Presence of an intravitreal device in the study eye.
- Previous radiation therapy to the study eye, head, or neck with the exception of radio-iodine treatment for hyperthyroidism, epimacular brachytherapy to the non-study eye, or Oraya SRT to the non-study eye.
- Inadequate pupillary dilation or significant media opacities in the study eye, including cataract, which may interfere with visual acuity testing, the clinical evaluation of the posterior segment, or fundus imaging.
- Study eyes with CNV due to causes other than AMD, including presumed ocular histoplasmosis syndrome (POH), angioid streaks, multifocal choroiditis, choroidal rupture, and pathological myopia (greater than 8 Dioptres spherical equivalent). Participants with retinal angiomatous proliferation (RAP) or idiopathic polypoidal choroidal vasculopathy (IPCV) are not excluded.
- Known allergy to intravenous fluorescein, ICG or intravitreal ranibizumab.
- Intraocular surgery or laser-assisted in situ keratomileusis (LASIK) in the study eye within 12 weeks prior to enrolment.
- Prior pars plana vitrectomy in the study eye.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- King's College Hospital NHS Trustlead
- King's College Londoncollaborator
Study Sites (30)
Bristol Eye Hospital
Bristol, Bristol, BS1 2LX, United Kingdom
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom
The Princess Alexandra Hospital
Harlow, Essex, CM20 1QX, United Kingdom
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Ashford William Harvey Hospital
Willesborough, Kent, TN24 0LZ, United Kingdom
James Paget University Hospital
Great Yarmouth, Norfolk, NR31 6LA, United Kingdom
Royal Hallamshire Hospital
Sheffield, South Yorkshire, S10 2JF, United Kingdom
Frimley Park Hospital
Frimley, Surrey, GU16 7UJ, United Kingdom
Stoke Mandeville Hospital
Aylesbury, HP21 8AL, United Kingdom
Heart Of England NHS Foundation Trust
Birmingham, B75 7RR, United Kingdom
Royal Blackburn Hospital
Blackburn, BB2 3HH, United Kingdom
Sussex Eye Hospital
Brighton, BN2 5BE, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Essex County Hospital
Colchester, C03 3NB, United Kingdom
Leighton Hospital
Crewe, CW1 4QJ, United Kingdom
Royal Derby Hospital
Derby, DE22 3NE, United Kingdom
Dorset County Hospital
Dorchester, DT1 2JY, United Kingdom
Calderdale Royal Hospital
Halifax, HX3 0PW, United Kingdom
Whipps Cross Hospital
Leytonstone, E11 1NR, United Kingdom
Lincoln Country Hospital
Lincoln, LN2 5QY, United Kingdom
Central Middlesex Hospital
London, NW10 7NS, United Kingdom
King's College Hospital NHS Foundation Trust
London, SE5 9RS, United Kingdom
Epsom and St. Helier Hospital
London, SM5 1AA, United Kingdom
Manchester Royal Eye Hospital
Manchester, M13 9WL, United Kingdom
Norfolk & Norwich University Hospital
Norwich, NR47UY, United Kingdom
Queen's Hospital
Romford, RM7 0AG, United Kingdom
Salisbury District Hospital
Salisbury, SP2 8BJ, United Kingdom
Hillingdon Hospital
Uxbridge, UB8 3 NN, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Yeovil District Hospital
Yeovil, BA21 4AT, United Kingdom
Related Publications (2)
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.
PMID: 38876132DERIVEDNeffendorf 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.
PMID: 27881184DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Timothy L Jackson, PhD FRCOphth
King's College Hospital NHS Trust
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2014
First Posted
September 18, 2014
Study Start
December 1, 2014
Primary Completion
December 1, 2021
Study Completion
April 1, 2024
Last Updated
August 6, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share