Abstract
Purpose: :
To report our interim results of treatment with intravitreal ranibizumab for radiation maculopathy following plaque radiotherapy for choroidal melanoma.
Methods: :
Ten patients were enrolled in an investigator sponsored, prospective, non-randomized consecutive case trial of plaque radiation therapy patients who subsequently developed radiation maculopathy. Entry criteria also included 1) more than 6 months after radiotherapy; 2) initial visual acuity of 20/400 or better; 3) subjective or objective loss of vision. Intravitreal injections of ranibizumab were given every 30 days (+/-7 days). Outcome measures included safety as measured by visual acuity (ETDRS), fundus photography, angiography, optical coherence tomography (OCT) and ultrasound imaging.
Results: :
Intravitreal ranibizumab was found to reduce retinal hemorrhage, exudation and macular edema. The most common and reproducible finding was decreased edema, with secondary restoration of the normal anatomy of the macula. The median time from plaque radiotherapy to enrollment in the trial was 21.5 months (range 6-67). The median time of follow-up in the study is 9.5 months (range 3-13). Our six (n=8) and twelve (n=5) month analysis demonstrated the following: 1) mean change in visual acuity of +8.0 (0 to +18) letters and +4.4 (+4 to -14) letters using ETDRS charts, respectively; 2) mean reduction in central foveal thickness of 31% (range 0-62) and 39% (20-57) on OCT imaging, respectively; and 3) mean reduction in tumor thickness of 10% (range 0-23) and 15% (range 0-23) on B-scan ultrasonography from pre-ranibizumab baseline, respectively. There were no significant adverse ocular or systemic side effects for up to one year of treatment.
Conclusions: :
Monthly intravitreal ranibizumab for radiation maculopathy was well tolerated for up to one-year of follow up. While reductions in retinal hemorrhage, exudate and macular edema were documented by photography and angiography; decreased macular retinal thickness was seen on OCT.
Clinical Trial: :
www.clinicaltrials.gov NCT00750399
Keywords: melanoma • radiation therapy • macula/fovea