Trial Examines Ranibizumab Injections and Vascular Pigment Epithelium Detachment in AMD Patients

Screen for morphological risk factors for an RPE tear before each injection.

Recently reported results of the prospective multicenter RECOVER trial indicate that a year of monthly ranibizumab injections can improve the best-corrected visual acuity (BCVA) of age-related macular degeneration (AMD) patients with serous vascular pigment epithelium detachment and improve their retinal morphology — as long as no tear in the retinal pigment epithelium (RPE) developed. In AMD patients whose pigment epithelium detachment (PED) was fibrovascular, RECOVER showed that this treatment regimen stabilized visual function and retinal morphology.

In the RECOVER study, Christoph Clemens, MD, and colleagues in the Department of Ophthalmology at Germany’s University of Muenster Medical Center evaluated the effects of 0.5-mg injections of ranibizumab (Lucentis/Roche) in 40 treatment-naïve AMD patients whose vascular pigment epithelium detachment (vPED) was at least 200 μm high.

The investigators divided these patients into two groups based on lesion type. One group included 29 patients with serous vascular PED, and the other included 11 patients with fibrovascular PED.

The investigators measured BCVA and used spectral-domain optical coherence tomography to evaluate patients at all visits. They also did fluorescein angiography and indocyanine green angiography at baseline and quarterly.

The investigators found little change in the primary outcome measure, BCVA, in each group when those in whom an RPE tear developed were included in the analysis. However, when they were excluded, BCVA increased from 56 ± 10 letters at baseline to 62 ± 10 letters by study end (P = 0.048) in the group with serous vascular PED. An RPE tear developed in 10 patients (25%) in this group after a mean of 3.6 injections. No RPE tear developed in the group with fibrovascular PED.

Secondary outcome measures included change in PED height and PED greatest linear diameter. These changes were much more pronounced in the group with serous vascular PED than in the group with fibrovascular PED. In the group with serous vascular PED, mean change in PED height was −427 ± 300 μm, and mean change in PED greatest linear diameter was −739 ± 788 μm. In contrast, in the group with fibrovascular PED, mean change in PED height was −52 ± 100 μm, and mean change in PED greatest linear diameter was −10 ± 186 μm.

Other secondary outcome measures included the presence of subretinal fluid and markers of an impending RPE tear. These markers included PED lesion height and diameter, presence of hyperreflective lines in near-infrared images, and the ratio of the size of the choroidal neovascularization (CNV) to the size of the PED.

The investigators noted statistically significant differences in each of these markers between patients in whom an RPE tear developed and those in whom it did not. Moreover, they concluded, “Monthly ranibizumab injections are an effective treatment regarding the resorption of subretinal fluid in vPED due to AMD.”

The results of the RECOVER trial also led the investigators to recommend screening patients to determine the presence of morphologic risk factors for an RPE tear before beginning ranibizumab as well as throughout the course of treatment.

The report, “Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study,” appeared in Acta Ophthalmologica online on January 13, 2017.

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