Abstract
Purpose: :
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.
Methods: :
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).
Results: :
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.
Conclusions: :
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.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01334879
Keywords: radiation therapy • edema • macula/fovea