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Response of vascular pigment epithelium detachment due to age‐related macular degeneration to monthly treatment with ranibizumab: the prospective, multicentre RECOVER study
Author(s) -
Clemens Christoph R.,
Wolf Armin,
Alten Florian,
Milojcic Carolin,
Heiduschka Peter,
Eter Nicole
Publication year - 2017
Publication title -
acta ophthalmologica
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.534
H-Index - 87
eISSN - 1755-3768
pISSN - 1755-375X
DOI - 10.1111/aos.13359
Subject(s) - ranibizumab , medicine , macular degeneration , ophthalmology , retinal pigment epithelium , choroidal neovascularization , fluorescein angiography , visual acuity , indocyanine green , prospective cohort study , retinal detachment , lesion , retinal , surgery , bevacizumab , chemotherapy
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. NCT 00976222). Inclusion criterion was a treatment‐naïve vPED lesion with a minimum height of ≥200 μ m. 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 (sv PED , 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 sv PED 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 μ m ± 285.5 (A: −427.3 μ m ± 299.7; B: −51.6 μ m ± 99.5). The mean decrease in PED GLD was −471.8 μ m ± 727.6 (A: −738.9 μ m ± 788.2; B: −10.4 μ m ± 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.