Stereotactic Radiotherapy for Wet AMD (STAR)

Sponsor
King's College Hospital NHS Trust
Study ID
NCT02243878
Phase
PHASE3
Status
Completed

Conditions

  • Neovascular (Wet) Age-related Macular Degeneration (AMD)

Eligibility Criteria

Sex
ALL
Age
50 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic radiotherapy (16 Gray or Sham) — RADIATION
    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.
  • 0.5 mg ranibizumab — DRUG
    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.

Study Details

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.

Key Dates

First listed
Sep 18, 2014
Start date
Dec 31, 2014
Status verified
Aug 2025
Primary completion
Dec 31, 2021
Completion
Apr 30, 2024

Study Design

Enrollment
411 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Number of as required (prn) ranibizumab injections during the first 24 months [ Time Frame: 24 months ]

Related Studies