Prospective randomized controlled trial of combination ranibizumab (lucentis) and bromfenac (xibrom) for neovascular age-related macular degeneration

A pilot study

Christina Flaxel, Mitchell B. Schain, Sara C. Hamon, Peter J. Francis

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Purpose: To evaluate whether bromfenac eyedrops and ranibizumab intravitreal injections would provide added efficacy over ranibizumab alone. Methods: This was a single-site, multiinvestigator, prospective, open-label, interventional, Phase II study of patients with new or recurrent exudative/neovascular age-related macular degeneration. Thirty eyes were enrolled consecutively and were randomized in a ratio of 2:1 to combination therapy with intravitreal ranibizumab and topical bromfenac, and ranibizumab alone. All patients received ranibizumab monthly therapy for 4 months then as needed monthly in accordance with standard of care. Patients receiving bromfenac self-administered 1 drop twice a day for 12 months. Patients were followed for 12 months. Results: There were no safety concerns with the combination therapy. No statistically significant differences were identified in Early Treatment Diabetic Retinopathy Study best-corrected visual acuity or the number of injections required. However, the mean 12-month change in central macular thickness in the combination group was -81.56 μm while in the ranibizumab group alone the change was -42.50 μm (P = 0.03). The proportion of eyes experiencing a decrease in CMT of 50 μm or more was also significantly higher in those receiving combination therapy (P = 0.046). Conclusion: This pilot study is the first to prospectively identify a biologic signal that may indicate combination therapy with an easily administered well-tolerated eyedrop and ranibizumab is efficacious for the treatment of neovascular age-related macular degeneration. Further studies are warranted to validate this finding.

Original languageEnglish (US)
Pages (from-to)417-423
Number of pages7
JournalRetina
Volume32
Issue number3
DOIs
StatePublished - Mar 2012

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Macular Degeneration
Randomized Controlled Trials
Ophthalmic Solutions
Therapeutics
Intravitreal Injections
Diabetic Retinopathy
Standard of Care
Ranibizumab
bromfenac
Visual Acuity
Safety
Injections

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Prospective randomized controlled trial of combination ranibizumab (lucentis) and bromfenac (xibrom) for neovascular age-related macular degeneration : A pilot study. / Flaxel, Christina; Schain, Mitchell B.; Hamon, Sara C.; Francis, Peter J.

In: Retina, Vol. 32, No. 3, 03.2012, p. 417-423.

Research output: Contribution to journalArticle

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