Anti-VEGF Therapy for Choroidal Neovascularisation
Anti-VEGF Therapy for Choroidal Neovascularisation
A retrospective, non-randomised, multicentre, consecutive, interventional case series study was performed on 92 eyes from 92 highly myopic patients (spherical equivalent (SE) >−6.0 dioptres and/or axial length >26.0 mm) from five different centres in Spain and Portugal with more than 4 years follow-up. Patients with retinal drusen in the study or fellow eye or any evidence of age-related macular degeneration were excluded. All patients had presented with active subfoveal classic CNV and had been treated by intravitreal injections (IVI) of anti-VEGF drugs. The treating drug (IVR 0.5 mg or IVB 1.25 mg) and initial protocol (loading dose 3 vs 1 injection) were dictated by surgeon's preference. After the initial dose an as-needed (PRN) monthly regimen was used.
The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki, and data gathering was performed after obtaining written informed consent from each patient and approval from the local ethics committees.
A complete ocular examination including determination of best corrected visual acuity (BCVA) and macular examination by spectral domain optical coherence tomography (SD-OCT) was performed at the first visit and then monthly during follow-up. BCVA was determined at 4 m using standard Early Treatment Diabetic Retinopathy Study (ETDRS) charts (Lighthouse, New York, USA) by certified optometrists. Fluorescein angiography (FA) was performed at baseline and whenever CNV activity was suspected. All patients completed the 4-year follow-up, attending at all visits. Patients previously treated by PDT were started on anti-VEGF therapy if they showed signs of CNV activity (decreased visual acuity associated with intraretinal or subretinal fluid and fluorescein leakage).
Patients were informed about the off-label condition of this therapy and women of childbearing age were also informed about the possible risks to the fetus; these patients agreed to use two forms of contraception (barrier and hormonal) throughout the following 3 months after injection. At each visit the patients were specifically asked about the appearance of systemic side effects (medication changes, high blood pressure, signs of cerebrovascular accidents, myocardial infarction or ischaemia) and ocular side effects (pain, floaters, reduced visual acuity).
The primary aim of the study was to analyse the changes in the number of letters read during the 4-year follow-up period after anti-VEGF therapy for subfoveal myopic CNV. The role of age (<50 vs ≥50 years of age), SE, anti-VEGF drug and previous PDT on the visual outcome were evaluated as secondary objectives.
Anti-VEGF re-injections were performed following the same criteria in all the centres during follow-up in those cases with signs of CNV activity: visual acuity loss ≥1 ETDRS line associated with increased central foveal thickness <30 microns and/or macular haemorrhage and/or increased intraretinal or subretinal fluid. FA was performed in order to confirm the presence of fluorescein leakage in the macular area.
Materials and Methods
A retrospective, non-randomised, multicentre, consecutive, interventional case series study was performed on 92 eyes from 92 highly myopic patients (spherical equivalent (SE) >−6.0 dioptres and/or axial length >26.0 mm) from five different centres in Spain and Portugal with more than 4 years follow-up. Patients with retinal drusen in the study or fellow eye or any evidence of age-related macular degeneration were excluded. All patients had presented with active subfoveal classic CNV and had been treated by intravitreal injections (IVI) of anti-VEGF drugs. The treating drug (IVR 0.5 mg or IVB 1.25 mg) and initial protocol (loading dose 3 vs 1 injection) were dictated by surgeon's preference. After the initial dose an as-needed (PRN) monthly regimen was used.
The study was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki, and data gathering was performed after obtaining written informed consent from each patient and approval from the local ethics committees.
A complete ocular examination including determination of best corrected visual acuity (BCVA) and macular examination by spectral domain optical coherence tomography (SD-OCT) was performed at the first visit and then monthly during follow-up. BCVA was determined at 4 m using standard Early Treatment Diabetic Retinopathy Study (ETDRS) charts (Lighthouse, New York, USA) by certified optometrists. Fluorescein angiography (FA) was performed at baseline and whenever CNV activity was suspected. All patients completed the 4-year follow-up, attending at all visits. Patients previously treated by PDT were started on anti-VEGF therapy if they showed signs of CNV activity (decreased visual acuity associated with intraretinal or subretinal fluid and fluorescein leakage).
Patients were informed about the off-label condition of this therapy and women of childbearing age were also informed about the possible risks to the fetus; these patients agreed to use two forms of contraception (barrier and hormonal) throughout the following 3 months after injection. At each visit the patients were specifically asked about the appearance of systemic side effects (medication changes, high blood pressure, signs of cerebrovascular accidents, myocardial infarction or ischaemia) and ocular side effects (pain, floaters, reduced visual acuity).
The primary aim of the study was to analyse the changes in the number of letters read during the 4-year follow-up period after anti-VEGF therapy for subfoveal myopic CNV. The role of age (<50 vs ≥50 years of age), SE, anti-VEGF drug and previous PDT on the visual outcome were evaluated as secondary objectives.
Anti-VEGF re-injections were performed following the same criteria in all the centres during follow-up in those cases with signs of CNV activity: visual acuity loss ≥1 ETDRS line associated with increased central foveal thickness <30 microns and/or macular haemorrhage and/or increased intraretinal or subretinal fluid. FA was performed in order to confirm the presence of fluorescein leakage in the macular area.
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