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Kimberly Hsu, Sam Pistorius, James Earl, Mouhammed Abuattieh, David Chin Yee, Prabakar K Rao; Intravitreal aflibercept for the treatment of macular edema associated with radiation retinopathy. Invest. Ophthalmol. Vis. Sci. 2014;55(13):1123. doi: https://doi.org/.
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To report the study design and interim results of a phase I clinical trial of intravitreal aflibercept injection (IAI) in the treatment of macular edema associated with radiation retinopathy.
This is a phase 1, double masked, randomized clinical trial to assess IAI in the treatment of patients with macular edema associated with radiation retinopathy. Twenty patients with retinopathy associated with previous brachytherapy for uveal melanoma will be randomized and included in the study. Patients will receive 3 initial monthly doses of IAI followed by randomization to receive an injection either every 4 weeks or every 8 weeks. Patients will be followed for 12 months. Primary outcome measures include incidence and severity of adverse events, and secondary outcome measures include mean change in visual acuity, mean change in central foveal thickness by OCT, and mean change in macular volume by OCT.
Three patients are currently enrolled in the study. One patient had a Grade I adverse reaction of nausea/syncope during an injection. The other two patients had no adverse events. The patients enrolled currently have a follow up of 9 months, 5 months, and 2 months. Visual acuity improved in all subjects, from 20/100 to 20/50, 20/125 to 20/40, and 20/30 to 20/20, respectively. Mean central foveal thickness and macular volume by OCT were also both improved in all subjects.
This is an ongoing, phase I, double blinded, randomized, active controlled study for intravitreal aflibercept in the treatment of macular edema associated with radiation retinopathy. Based on this interim data, IAI may be an option for these patients. There is currently no approved therapy for radiation retinopathy, and this trial will be an important step toward assessing the feasibility of treatment with intravitreal aflibercept.
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