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Paul T. Finger, Kimberly J. Chin; Preliminary Findings of Intravitreal High Dose (2.0 mg) Ranibizumab for Recalcitrant Radiation Maculopathy. Invest. Ophthalmol. Vis. Sci. 2012;53(14):3426.
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To report our interim results of intravitreal high-dose (2.0 mg) ranibizumab for radiation maculopathy (RM) in patients with recalcitrant disease despite periodic continuous treatment with commercially available anti-VEGF therapy.
Ten patients were enrolled in an FDA-approved, investigator-sponsored, prospective pilot study. Patients developed RM subsequent to plaque brachytherapy for uveal melanoma (n=8) or external beam radiation therapy (n=2). Entry criteria also included a previous history of commercially available intravitreal anti-VEGF therapy. Patients were assigned in an alternating manner to one of two groups: 1) 4 initial monthly injections followed by monthly injections as determined by study criteria, or 2) monthly injections as determined by study criteria. Intravitreal ranibizumab was given every 30 days (+/-7 days). Outcome measures included safety and tolerability, and treatment effect as measured by visual acuity (ETDRS), ophthalmoscopy, photography, angiography and optical coherence tomography (OCT).
There were 7 females and 3 males, with a mean age of 55 years (range 31-87). At the time of this report, there has been a mean 5 monthly injections (range 3 to 6).In all cases, high-dose intravitreal ranibizumab was found to reduce retinal hemorrhage, exudation and macular edema beyond what was seen with standard dose therapy. Interim results were as follows: All 10 patients had stable (n=3) or improved (n=7) visual acuity with a mean improvement of +4 letters (range 0-12). Central foveal OCT thickness was stable or improved in 70% of patients, with a mean thickness reduction of -25% (range +7 to -50%). There were no significant adverse ocular or systemic side effects at this interval. There was no difference in the number of injections for the 2 groups. Based on clinical exam, no patient has been able to extend treatment beyond the monthly injection protocol.
Monthly intravitreal high dose ranibizumab for radiation maculopathy was well tolerated for up to 6 months. In this subset of patients with persistent RM despite previous (commercially available) anti-VEGF therapy, high dose ranibizumab was able to further reduce retinal thickness and improve visual acuity in select patients. These results suggest a role for a high dose of ranibizumab, though longer follow-up is needed.
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