Condition category
Eye Diseases
Date applied
28/11/2014
Date assigned
13/12/2014
Last edited
25/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Age-related macular degeneration (AMD) is a painless eye condition that leads to loss of central vision. There are two main types of AMD, called dry AMD and wet AMD. Wet AMD is more serious and without treatment, vision can deteriorate within days. This study investigates the use of radiation to treat wet AMD, called stereotactic radiosurgery. 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. This study aims to determine if stereotactic radiosurgery can maintain vision and reduce the need for regular injections of ranibizumab (the standard anti-VEGF drug used to treat wet AMD).

Who can participate?:
Males and females aged 50 years or over with wet AMD requiring anti-VEGF treatment at the time of entry to the study.

What does the study involve?
Participants will be randomly allocated to receive either radiation (stereotactic radiotherapy) or simulated placebo (sham) treatment. 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.

What are the possible benefits and risks of participating?
The main benefit of stereotactic radiotherapy is that it may reduce the number of eye injections that people require, or in some cases eliminate them entirely. Previous studies have suggested that the patients who will be eligible for the study would obtain a better vision outcome with radiotherapy (with injections as needed) than with injections alone. The main risk of radiation is that it can sometimes damage the healthy tissue in the macula and thereby damage vision. Subtle changes to the macula can sometimes be seen using specialised testing (fluorescein angiography) but in the majority of people this does not affect the vision.

Where is the study run from?
King's College Hospital (UK).

When is the study starting and how long is it expected to run for?
Recruitment to the study will begin in December 2014 and continue for approximately 41 months. Each participant will be in the study for 4 years.

Who is funding the study?
NIHR Efficacy and Mechanism Evaluation Programme (UK).

Who is the main contact?
Mr Tim Jackson
t.jackson1@nhs.net

Trial website

www.starstudy.org.uk

Contact information

Type

Scientific

Primary contact

Dr Tim Jackson

ORCID ID

Contact details

King’s College London
Department of Ophthalmology
King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 1297
t.jackson1@nhs.net

Type

Public

Additional contact

Mrs Riti Desai

ORCID ID

Contact details

Ophthalmology Department
Research Office
1st Floor
Normanby Building
King's College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom
+44 (0)20 3299 1297
ritidesai@nhs.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02243878

Protocol/serial number

Version 1.3 (25 October 2014)

Study information

Scientific title

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

Acronym

STAR

Study hypothesis

The study’s primary hypothesis is that the mean number of ranibizumab injections during the first 24 months after randomization will be less in the SRT group than in the sham group. The secondary hypothesis is that participants who undergo SRT will have a non-inferior visual outcome compared with those in the sham group.

Ethics approval

NRES Committee London - City & East, REC ref: 13/LO/1207

Study design

Randomised double-masked sham-controlled pivotal clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Retinal disease/age-related macular degeneration

Intervention

Participants in the treatment arm will receive 16 Gray stereotactic radiotherapy (SRT) with a concomitant injection of ranibizumab.

Intervention type

Device

Phase

Drug names

Primary outcome measures

The primary outcome is the mean number of ranibizumab injections over 24 months. SRT will be considered superior to sham if the mean number of injections in the SRT group is statistically less than (one-sided p<0.025) the mean in the sham group.

Secondary outcome measures

SRT will be considered non-inferior to sham treatment if the lower bound of the 95% confidence interval for the difference in mean change in ETDRS VA at 24 months, between the SRT and sham groups, is no greater than 5 letters.

Overall trial start date

01/12/2014

Overall trial end date

31/10/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must have neovascular AMD in the study eye, for which they have received at least three prior intravitreal injections of either bevacizumab (Avastin), aflibercept (Eylea), ranibizumab (Lucentis) or pegaptanib (Macugen)
2. Participants must have received an anti-VEGF injection in the study eye within 3 months prior to enrolment
3. 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 a macular volume that is greater than the 95th percentile of normal for the SD-OCT machines used in the investigational sites
4. Participants must be at least 50 years of age

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

411

Participant exclusion criteria

1. Disciform scarring that involves the fovea, in the study eye
2. Geographic atrophy that involves the fovea, or an area of geographic atrophy that is more than 500 microns in greatest diameter, immediately adjacent to the fovea, in the study eye
3. Visual acuity worse than 6/96 (24 ETDRS letters) in the study eye
4. 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
5. Distance from the center of the fovea to the nearest edge of the optic disc less than 3 mm in the study eye (this distance is confirmed by the Oraya SRT device software immediately prior to treatment)
6. An axial length of less than 20 mm, or greater than 26 mm, in the study eye
7. Contraindication or sensitivity to contact lens application, including recurrent corneal erosions, in the study eye
8. Type 1 or Type 2 diabetes mellitus
9. Retinopathy in the study eye
10. 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)
11. Presence of an intravitreal device in the study eye
12. 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
13. 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
14. Likely to need cataract surgery in the study eye within two years of enrolment
15. 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
16. Known allergy to intravenous fluorescein, ICG or intravitreal ranibizumab
17. Intraocular surgery or laser-assisted in situ keratomileusis (LASIK) in the study eye within 12 weeks prior to enrolment
18. Prior pars plana vitrectomy in the study eye
19. Current participation in another interventional clinical trial, or participation in such a clinical trial within the last six months
20. Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial
21. Women who are pregnant at the time of radiotherapy
22. Participants with an implantable cardioverter defibrillator (ICD) or pacemaker implant (or any implanted device) where the device labelling specifically contraindicates patients undergoing X-ray
23. Any other condition, which in the judgment of the investigator, would prevent the participant from granting informed consent or completing the study, such as dementia and mental illness (including generalized anxiety disorder and claustrophobia)

Recruitment start date

01/12/2014

Recruitment end date

30/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

King's College Hospital
Ophthalmology Department Normanby Building Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor information

Organisation

King's College Hospital NHS Foundation Trust

Sponsor details

King’s College Hospital
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

https://www.kch.nhs.uk/research

Organisation

King's College London

Sponsor details

Strand Campus
The Strand
London
WC2R 2LS
United Kingdom

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Government

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27881184

Publication citations

Additional files

Editorial Notes

25/11/2016: Publication reference added.