The purpose of this study is to assess the safety of intravitreal aflibercept injection - in the treatment of macular edema associated with retinopathy secondary to previous radiation therapy.
Radiation retinopathy can cause decreased vision in patients who have received either external beam radiation or local plaque therapy to the eye. An early manifestation of radiation retinopathy is macular edema, which represents fluid within the retina that affects central vision. There is currently no approved treatment for this disease, although there have been anecdotal reports of benefit with laser photocoagulation, intravitreal anti-VEGF agents, or intravitreal steroid use. This is a phase 1 study to evaluate aflibercept for the treatment of macular edema associated with retinopathy secondary to previous radiation treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
9
2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
2.0mg aflibercept intravitreal injections every month (M0-11)
Washington University School of Medicine
St Louis, Missouri, United States
Retina Consultants of Houston
Houston, Texas, United States
Incidence of adverse events
Time frame: 12 months
Severity of adverse events
Time frame: 12 months
Mean change in best corrected visual acuity from baseline
Time frame: 12 months
Mean change in central foveal thickness by optical coherence tomography (OCT) from baseline
Time frame: 12 months
Mean visual acuity
Time frame: 12 months
Mean central foveal thickness
Time frame: 12 months
Proportion of patients gaining 3 lines of vision
Time frame: 12 months
Mean change in lesion characteristics (lesion size, leakage)
Time frame: 12 months
Proportion of patients with no fluid on OCT
Time frame: 12 months
Mean change in macular volume
Time frame: 12 months
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