Response of vascular pigment epithelium detachment due to age-related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study

Abstract

Purpose: To assess the effects of monthly intravitreal ranibizumab injections in patients with vascularized pigment epithelium detachment (vPED) secondary to age-related macular degeneration (AMD).

Methods: A total of 40 patients were prospectively observed and treated monthly with 0.5 mg ranibizumab injections (ClinicalTrials.gov Ident. NCT00976222). Inclusion criterion was a treatment-naïve vPED lesion with a minimum height of ≥200 μm. Best-corrected visual acuity (BCVA) and spectral-domain optical coherence tomography (SD-OCT) were evaluated at all visits. Fluorescein angiography and indocyanine green angiography were performed at baseline and quarterly. Lesions were differentiated between serous vascular PED (svPED, group A, 29 patients) and fibrovascular PED (fPED, group B, 11 patients). Primary outcome was the effectivity of continuous monthly treatment during a 12-month period as measured in change in BCVA. Secondary outcomes were change in PED height and PED greatest linear diameter (GLD). Further secondary outcomes were the presence of subretinal fluid and prognostic markers of an impending retinal pigment epithelium (RPE) tear: PED lesion height and diameter, ratio of choroidal neovascularization (CNV) size to PED size, hyperreflective lines in near-infrared images, microrips and subretinal cleft.

Results: Mean BCVA was 56.9 ± 11.5 letters (A: 55.4 ± 10.8; B: 59.1 ± 13.4) at baseline and 55.1 ± 15.9 (A: 53.7 ± 17.0; B: 58.9 ± 12.7) at 12-month follow-up. Excluding the RPE tear patients, the svPED group showed an increase in BCVA from 56.1 ± 10.3 at baseline to 62.4 ± 10.2 at 12-month follow-up (p = 0.048). Best-corrected visual acuity in patient who developed a RPE tear was 55.8 ± 12.5 at baseline and 37.1 ± 14.9 at 12-month follow-up. The mean change in PED height was -242.1 μm ± 285.5 (A: -427.3 μm ± 299.7; B: -51.6 μm ± 99.5). The mean decrease in PED GLD was -471.8 μm ± 727.6 (A: -738.9 μm ± 788.2; B: -10.4 μm ± 185.6). In group A, 10 patients developed a RPE tear (25%) after a mean of 3.6 injections. No tear was documented in group B. Lesion height, ratio of CNV size to PED size and presence of hyperreflective lines differed significantly between patients with and without RPE tear development.

Conclusion: Serous vascular PED lesions showed an improvement regarding BCVA and morphologic characteristics unless an RPE tear occurred. In fPED lesions, a functional and morphological stabilization was observed. Monthly ranibizumab injections are an effective treatment regarding the resorption of subretinal fluid in vPED due to AMD. Patients should be screened for the presence of morphologic risk factors for RPE tear development before and during treatment.

Keywords: age-related macular degeneration; antivascular endothelial growth factor; confocal scanning laser ophthalmoscopy; pigment epithelium detachment; ranibizumab; retinal pigment epithelium tear; spectral-domain optical coherence tomography.

© 2017 Acta Ophthalmologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.