Status:
COMPLETED
Stereotactic Radiotherapy for Wet AMD (STAR)
Lead Sponsor:
King's College Hospital NHS Trust
Collaborating Sponsors:
King's College London
Conditions:
Neovascular (Wet) Age-related Macular Degeneration (AMD)
Eligibility:
All Genders
50-110 years
Phase:
PHASE3
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 ra...
Detailed Description
Age-related macular degeneration (AMD) leads more people to go blind than all other eye diseases combined. 'Wet' AMD occurs when abnormal new blood vessels grow into the macula. The macula is an area ...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- 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.
- Exclusion Criteria
- 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.
- Current participation in another interventional clinical trial, or participation in such a clinical trial within the last six months.
- Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
- Women who are pregnant at the time of radiotherapy.
- Participants with an implantable cardioverter defibrillator (ICD) or pacemaker implant (or any implanted device) where the device labelling specifically contraindicates patients undergoing X-ray.
- 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).
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2024
Estimated Enrollment :
411 Patients enrolled
Trial Details
Trial ID
NCT02243878
Start Date
December 1 2014
End Date
April 1 2024
Last Update
August 6 2025
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
Bristol Eye Hospital
Bristol, Bristol, United Kingdom, BS1 2LX
2
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
3
The Princess Alexandra Hospital
Harlow, Essex, United Kingdom, CM20 1QX
4
Maidstone Hospital
Maidstone, Kent, United Kingdom, ME16 9QQ