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Stereotactic radiotherapy for the treatment of neovascular age-related macular degeneration: year 2 safety outcomes of the INTREPID trial

Session Details

Session Title: AMD I

Session Date/Time: Thursday 26/09/2013 | 08:30-10:30

Paper Time: 08:46

Venue: Hall 1 (Level 2)

First Author: T.Jackson UK

Co Author(s):    U. Chakravarthy   M. Shusterman   D. Moshfeghi   J. Slakter     

Abstract Details

Purpose:

To assess the safety of stereotactic radiotherapy (SRT) for neovascular age-related macular degeneration (AMD) over 2 years.

Setting:

21 European sites.

Methods:

230 patients with active, chronic, neovascular AMD were entered into a double masked, sham controlled, randomized clinical trial. Of this group, 226 received the allocated treatments of 16 Gray (N=74), 24 Gray (N=73) or sham SRT (N=79). Participants were administered 0.5 mg intravitreal ranibizumab at baseline, and thereafter for one year using a monthly as needed dosing regimen with pre-defined retreatment criteria. Efficacy follow-up continued for 12 months. After month 12, patients resumed usual standard of care, but returned for a safety visit at month 24. Safety outcomes included adverse events (AEs) and serious AEs (SAEs), coded using MedDRA preferred terms. Fundus photographs and fluorescein angiograms were obtained at baseline and months 12 and 24, and additional colour photographs were obtained at months 6 and 18. All images were reviewed by a masked, independent reading centre for the presence of microvascular changes potentially associated with radiation retinopathy. Cases with suspicious features were referred to a panel of experts for further evaluation.

Results:

The study met its primary endpoint, with a statistically significant reduction in ranibizumab retreatment over 12 months. The 24 month safety data will be presented, including the number of AEs, SAEs, and microvascular findings.

Conclusions:

SRT appeared to be safe over 2 years, with an acceptable risk profile. No SRT-related clinically significant AEs or SAEs were noted, and retinal vascular changes were confined to non-vision-threatening microangiopathy.

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