ABSTRACT
BACKGROUND: Double-blind, randomised, placebo-controlled and multicentre studies have proven an increase in visual acuity in one-third of the patients receiving Ranibizumab (0.5 mg) injections, who suffer from exsudative AMD. The purpose of this study was to evaluate the early effects of intravitreal Ranibizumab therapy in patients with mainly occult neovascular AMD in clinical applications. PATIENTS AND METHODS: In a retrospective cohort study, 91 eyes with occult and classic neovascular AMD were treated with intravitreal injections of Ranibizumab (0.5 mg) at 30-day intervals. The treatment effects were evaluated according to best corrected visual acuity, optical coherence tomography (OCT) and intraocular pressure at baseline as well as 1, 3 and 6 months after the beginning of therapy. Furthermore, fluorescein angiography (FLA) was performed at baseline as well as 3 and 6 months after therapy. RESULTS: 74 % of the patients lost fewer than 15 letters on the EDTRS-scale 6 months after the beginning of therapy. Visual acuity improved by more than 15 letters in 11 % of the patients. Central retinal thickness, measured by OCT, decreased statistically significantly in each control compared to baseline (1 month: p = 0.045; 3 months: p = 0.001; 6 months: p = 0.006). Leakage and membranes, evaluated in FA, worsened in 31 % of the patients; in 67 % the findings were stable. No increase in intraocular pressure was detected. CONCLUSIONS: Intravitreal application of Ranibizumab was safe and well tolerated. In the clinical situation, visual acuity was stabilised in the short term. As opposed to phase-III studies, no improvement in visual acuity could be accomplished. Cental retinal thickness decreased and findings in fluorescein angiography were stable within a 6-month follow-up period. It is necessary to perform monthly controls and proceed with VA- and OCT-based injections in order to maintain the therapeutic effect. Futher clinical evaluations of Ranibizumab will be necessary to evaluate its long-term treatment effects.
Subject(s)
Antibodies, Monoclonal/administration & dosage , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Vision Disorders/diagnosis , Vision Disorders/prevention & control , Vitreous Body , Wet Macular Degeneration/complications , Wet Macular Degeneration/drug therapy , Aged, 80 and over , Antibodies, Monoclonal, Humanized , Cohort Studies , Female , Humans , Injections, Intralesional , Male , Middle Aged , Ranibizumab , Retrospective Studies , Treatment OutcomeABSTRACT
PURPOSE: The aim of this study is to discuss the effect and outcome of a combined photodynamic therapy and intravitreal injection of ranibizumab (0.5 mg) in occult CNV with recent disease progression and in classic choroidal neovascularization (CNV) due to AMD. METHODS: In a pilot study in 28 patients (17 classic, 11 occult CNV) an intravitreal injection of ranibizumab was administered within 12 to 24 hours after standard PDT, followed by 2 injections of ranibizumab after 1 and 2 months. Before as well as 3 and 6 months after treatment visual acuity, OCT examinations (retinal thickness) and fluorescein angiography were performed. RESULTS: Mean visual acuity was significantly improved compared to baseline after 3 months (VA baseline 20/80, after 3 months 20/50, and 20/63 after 6 months). We found no choroidal hypoperfusion and no RPE rip. OCT and fluorescein angiography in patients with occult and classic choroidal neovascularisation after the combination therapy showed a reduced retinal thickness (baseline: 307 microm, after 1 month: 210 microm, after 3 months: 228 microm and after 6 months 281 microm) and a reduction of leakage compared to baseline. CONCLUSIONS: Photodynamic therapy combined with injection of intravitreal ranibizumab was well tolerated and is effective. We found a stabilisation of VA in 96% of patients. Our short-term results are very promising. Further studies are necessary to show the long-term effect of the PDT and anti-VEGF combination therapy.
