Role of Intravitreal Aflibercept Injection for the Treatment of Radiation Maculopathy

This study will consist of 2 simultaneous treatment arms: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward. Treatment will be given at each visit. Patients with improved radiation maculopathy (SD-OCT analysis) will extend re-evaluation by two weeks (e.g. first interval 6 weeks; second interval 10 weeks; third interval 12 weeks, etc). Patients with increased radiation maculopathy (SD-OCT analysis) will have re-evaluation decreased by one week. Both arms will consist of 25 subjects (eyes). Fluorescein angiography will be completed at baseline, after the 4th injection (or within three weeks of week 24 for the TAE arm), and at the end of the study in all patients. Spectral domain OCT, and clinical evaluation including visual acuity will be assessed every visit in all patients. Radiation maculopathy will be graded every visit in all patients in a blinded fashion using the following classification system: Grade 1 indicates extrafoveal, noncystoid edema; grade 2, extrafoveal cystoid edema; grade 3, foveal noncystoid edema; grade 4, mild-to-moderate foveal cystoid edema; grade 5, severe foveal cystoid edema and grade 6 subretinal fluid. All patients will undergo comprehensive evaluation including adverse event questioning at each study timepoint. Patients in the six-week dosing arm will receive a total of 9 intravitreal aflibercept injections during the study window while the TAE treatment group will receive a maximum of 9 with a minimum of 5.