Results of a prospective, randomized pilot study suggest that a topical nonsteroidal anti-inflammatory drug, bromfenac 0.09%, may be a useful addition to an anti-vascular endothelial growth factor agent, intravitreal ranibizumab, in patients being treated for exudative age-related macular degeneration.
Recently published online [Retina 2011 Aug 20; Epub ahead of print], the study was a multi-investigator, open-label, single-institution clinical trial conducted at the Casey Eye Institute, Oregon Health & Science University, Portland. It randomly assigned 30 consecutively enrolled eyes with new or recurrent exudative AMD 2:1 to combination therapy with ranibizumab 0.5 mg and bromfenac or to ranibizumab alone. All patients received monthly ranibizumab injections for 4 months. They were followed at monthly intervals and were re-treated with ranibizumab based on protocol-specified clinical and optical coherence tomography (OCT) criteria. Patients in the combination group used bromfenac twice daily.
At the primary endpoint at 12 months, no safety concerns were identified for the combination regimen, noted Christina J. Flaxel, MD, professor of ophthalmology, Casey Eye Institute.
"There is interest in identifying strategies for improving responses to intravitreal ranibizumab and reducing the frequency of injections," Dr. Flaxel said. "Considering its anti-inflammatory activity and retinal bioavailability with topical administration, bromfenac is an attractive alternative.
"Although the combination regimen had no benefit for improving functional outcomes or decreasing the injection burden in this small study, the anatomic benefit is encouraging and suggests further investigation is warranted," she said. "We are now collaborating with the manufacturers of the two medications and hope to launch larger multicenter, randomized, controlled trials in the future."