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Promising Therapy for radiation maculopathy

Intravitreal pharmacotherapy may moderate anatomic and visual effects of radiation-associated maculopathy

Sean Henahan

Posted: Wednesday, January 11, 2017

Timothy Murray MD
Timothy Murray MD

Intravitreal aflibercept (EYLEA®, Regeneron Pharmaceuticals, Inc.) appears to be a promising therapy for radiation maculopathy resulting from I-25 brachytherapy of uveal melanoma, suggest interim data from the first randomised clinical trial to evaluate anti-vascular endothelial growth factor (anti-VEGF) agents for this indication.

“There has recently been strong interest in the ocular oncology community in the use of intravitreal pharmacotherapy to moderate the anatomic and visual effects of radiation-associated maculopathy,” Timothy Murray MD, Miami, Florida, told a session of the 34th Annual Meeting of the American Society of Retina Specialists in San Francisco.

Dr Murray presented an interim analysis of 29 patients enrolled in the ongoing prospective, randomised, controlled study. All patient had undergone successful I-125 globe-salvaging plaque brachytherapy using the Collaborative Ocular Melanoma Study (COMS) protocol. The COMS protocol consists of iodine 125 brachytherapy and COMS configured plaque with 85 gray treatment to the tumour apex and a minimum 2.0mm margin. All patients had confirmed advanced radiation maculopathy (grade 4-5) resulting from treatment. They were randomised into two groups, the first group receiving 2.0mg intravitreal aflibercept every six weeks, and the second undergoing a treat-and-extend treatment with the same dose based on evaluations conducted every six weeks.

At the time of enrolment, patients had a mean best corrected visual acuity (BCVA) of 20/80, with mean central foveal thickness on spectral domain optical coherence tomography (SD-OCT) of 487 microns. The interim analysis of patients with a mean follow-up of six months after beginning aflibercept injections showed a statistically significant reduction in OCT central point thickness, from 487 microns to 380 microns at two months, and down to 312 microns at six months.

“Of most importance to the patients, at two months visual acuity had improved to 20/51, and at six months had improved to 20/32. At the six-month mark, 95% of our patients had achieved 20/40 or better,” reported Dr Murray.

Of most importance to the patients, at two months visual acuity had improved to 20/51, and at six months had improved to 20/32

He described several cases where patients demonstrated dramatic improvement. One such case was a 76-year-old patient who had 20/400 BCVA at the beginning of the study. After receiving anti-VEGF treatment at six week intervals he improved to 20/30, with significant improvement also noted on OCT.

Another patient, enrolled eight months post-brachytherapy, presented with both radiation maculopathy and optic neuropathy. After 66 weeks on the treat-and-extend protocol she also showed marked improvement on her OCT, with visual acuity improving from 20/400 to 20/30.

“Ultimately, this interim data does suggest the potential for a large, multicentre randomised controlled clinical trial, and supports the recent shift within the ocular oncology community to the use of intravitreal pharmacotherapy in the management of radiation-related complications in uveal melanoma,” Dr Murray concluded.

Timothy Murray: tmurray@murraymd.com