MedTrace Logo

Stereotactic Radiotherapy for Wet AMD (STAR)

NCT02243878 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 411

Last updated 2025-08-06

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Timothy L Jackson, PhD FRCOphth · King's College Hospital NHS Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
110 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2021-12-31
Completion
2024-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02243878 on ClinicalTrials.gov