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Intravitreal Ranibizumab Study Finds Few Non-Responders among AMD Patients

At the one-month follow-up exam, only 7% were functional non-responders, half of whom were reclassified as responders at 6-month follow-up.

To determine the proportion of eyes affected by subfoveal choroidal neovascularization owing to age-related macular degeneration (AMD) that do not respond to intravitreal injections of ranibizumab (Lucentis/Roche), Pierluigi Iacono, MD, and colleagues at the Department of Ophthalmology, Ospedale San Raffaele, in Milan, Italy, did a six-month study of 53 Lucentis-treated eyes.

Study patients received three monthly injections of intravitreal Lucentis, then monthly retreatment(s) on a pre re nata basis if fluid on optical coherence tomogram, leakage on fluorescein angiogram, or new hemorrhages were noted. The study’s primary outcome measure was the proportion of non-responders who showed no response to treatment during follow-up examinations.

The study investigators classified Lucentis-treated patients as functional, anatomical, or complete non-responders. Functional non-responders had a worsening of best-corrected visual acuity indicated by the loss of at least two lines on the Early Treatment of Diabetic Retinopathy Study (ETDRS) scale. Anatomical non-responders did not show a ≥10% decrease in central foveal thickness compared with the baseline value. Complete non-responders met both the anatomical and the functional criteria for non-response.

On the basis on findings at the one-month follow-up examination, the investigators classified four of the 53 patients (7%) as functional non-responders. However, at the six-month follow-up examination, half of these initial functional non-responders (two patients) were reclassified as functional responders.

Furthermore, on the basis on findings at the one-month follow-up examination, the investigators classified 23 of 53 eyes (43%) as anatomical non-responders. However, 16 of these 23 initially anatomically non-responsive eyes, or 70%, showed an anatomical response to treatment during one of the remaining follow-up examinations.

The investigators classified two of the 53 study eyes, or 4%, as complete non-responders at the 1-month follow-up examination. However, the proportion of complete non-responders decreased to zero at the three-month follow-up examination and was only 2% at the 6-month follow-up examination. Thus, as the investigators noted, no initially completely non-responsive eye remained completely non-responsive throughout the follow-up period.

As a result of these findings, the study investigators concluded that their data “indicate a low proportion of functional and anatomical non-responders” to intravenous Lucentis injections in AMD patients with subfoveal choroidal neovascularization. They recommended further study to refine the definition of non-responder and get a better idea of the magnitude of the response, when present, to intravitreal Lucentis injections in these patients.

The report of the study, “Non-responders to intravitreal ranibizumab in subfoveal choroidal neovascularization secondary to age-related macular degeneration,” was published in the January, 2017, issue of Ophthalmic Research.

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