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Stereotactic Radiotherapy for Wet AMD (STAR) (STAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02243878
Recruitment Status : Active, not recruiting
First Posted : September 18, 2014
Last Update Posted : April 4, 2022
Sponsor:
Collaborator:
King's College London
Information provided by (Responsible Party):
King's College Hospital NHS Trust

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.

Condition or disease Intervention/treatment Phase
Neovascular (Wet) Age-related Macular Degeneration (AMD) Radiation: Stereotactic radiotherapy (16 Gray or Sham) Drug: 0.5 mg ranibizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 411 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Study Start Date : December 2014
Actual Primary Completion Date : December 2021
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Arm A (treatment)

Participants 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.

Radiation: Stereotactic radiotherapy (16 Gray or Sham)
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.

Drug: 0.5 mg ranibizumab
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.
Other Name: Lucentis®

Sham Comparator: Arm B (control)

Participants 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.

Radiation: Stereotactic radiotherapy (16 Gray or Sham)
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.

Drug: 0.5 mg ranibizumab
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.
Other Name: Lucentis®




Primary Outcome Measures :
  1. Number of as required (prn) ranibizumab injections during the first 24 months [ Time Frame: 24 months ]
    Monitor the number of eye injections


Secondary Outcome Measures :
  1. Mean Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity (VA) at 24 months. [ Time Frame: 24 months ]
    Measure the visual function on an eye chart



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 110 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  1. 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).
  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 have 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.

Exclusion Criteria

  1. Disciform scarring that involves the fovea, in the study eye.
  2. Visual acuity worse than 6/96 (24 ETDRS letters) in the study eye.
  3. 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.
  4. An axial length of less than 20 mm, or greater than 26 mm, in the study eye.
  5. Contraindication or sensitivity to contact lens application, including recurrent corneal erosions, in the study eye.
  6. Type 1 or Type 2 diabetes mellitus.
  7. Retinopathy in the study eye.
  8. 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).
  9. Presence of an intravitreal device in the study eye.
  10. 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.
  11. 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.
  12. 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.
  13. Known allergy to intravenous fluorescein, ICG or intravitreal ranibizumab.
  14. Intraocular surgery or laser-assisted in situ keratomileusis (LASIK) in the study eye within 12 weeks prior to enrolment.
  15. Prior pars plana vitrectomy in the study eye.
  16. Current participation in another interventional clinical trial, or participation in such a clinical trial within the last six months.
  17. Unwilling, unable, or unlikely to return for scheduled follow-up for the duration of the trial.
  18. Women who are pregnant at the time of radiotherapy.
  19. Participants with an implantable cardioverter defibrillator (ICD) or pacemaker implant (or any implanted device) where the device labelling specifically contraindicates patients undergoing X-ray.
  20. 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02243878


Locations
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Sponsors and Collaborators
King's College Hospital NHS Trust
King's College London
Investigators
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Principal Investigator: Timothy L Jackson, PhD FRCOphth King's College Hospital, London
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT02243878    
Other Study ID Numbers: UKCRN ID 18040
ISRCTN12884465 ( Registry Identifier: International Standard Randomised Controlled Trial Number(ISRCTN) )
EME-Project:12/66/22 ( Other Grant/Funding Number: National Institute for Health Research )
First Posted: September 18, 2014    Key Record Dates
Last Update Posted: April 4, 2022
Last Verified: April 2022
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents