Article Text
Abstract
Objective: To evaluate safety of same-day administration of verteporfin and ranibizumab.
Methods: Prospective, open-label, multicentre study; patients with predominantly classic (n = 13) or occult (n = 19) choroidal neovascularisation secondary to age-related macular degeneration received standard-fluence verteporfin at baseline and months 3, 6 and 9, based on fluorescein angiography (FA). Ranibizumab 0.5 mg was administered at baseline and months 1, 2 and 3.
Main outcome measure: The incidence of severe vision loss (best-corrected visual acuity (BCVA) loss ⩾30 letters; primary safety assessment).
Results: No severe vision loss due to ocular inflammation or uveitis occurred. One patient had moderate vision loss (BCVA loss ⩾15 letters). Three patients had mild/moderate uveitis. Two serious ocular adverse events occurred (retinal pigment epithelial tear and moderate BCVA decrease). No systemic adverse events occurred. At 9 months, all lesions were inactive with no recurrent leakage on FA and optical coherence tomography; macular oedema and subretinal fluid resolved. The mean BCVA measured at 2 m improved by 6.9 letters at 4 months and 2.4 letters at 9 months.
Conclusions/application to clinical practice: Same-day verteporfin and ranibizumab was safe and not associated with severe vision loss or severe ocular inflammation. Lesions stabilized, with minimal treatment required after month 3.
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Footnotes
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Funding: This study was supported by Novartis Pharma AG, Basel, Switzerland.
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Competing interests: US-E is an inventor on the patent on the use of verteporfin in ocular vascular disease under the guidelines of the Wellman Laboratories patent policy/Harvard Medical School. She has received financial support from Novartis Pharma AG for travel expenses and contributions to conferences and advisory boards and institutional support for commercially sponsored studies. SW has received financial support from Novartis Pharma AG for travel expenses and contributions to conferences and advisory boards and institutional support for commercially sponsored studies. He has received financial support from Pfizer Inc. and Allergan Inc. for travel expenses and advisory boards.
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Ethics approval: Ethics approval was provided by the Ethics Committee of the Medical University of Vienna.
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Patient consent: Obtained.