Abstract
Purpose: :
To evaluate same-day, reduced-fluence rate photodynamic therapy (PDT) plus intravitreal ranibizumab in the treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). We also determined whether this combination decreases the frequency of reinjections using to a variable dosing regimen, as compared to ranibizumab monotherapy.
Methods: :
This prospective, nonrandomized, interventional case series enrolled twenty-eight consecutive patients (30 eyes) presenting with previously untreated, active neovascular AMD. Occult CNV was present in 67% of the study eyes and retinal angiomatous proliferative (RAP) lesions in 23%. The remaining 3 eyes (10%) had classic, predominantly classic or minimally classic CNV (one each). All patients were treated with same-day reduced-fluence rate verteporfin PDT (25 J/cm2) and intravitreal ranibizumab. A second and third ranibizumab injection was given at weeks 4 and 8, after which patients were seen monthly for 18 months. Additional treatment with ranibizumab was given to eyes with active CNV based on clinical and imaging (OCT and fluorescein angiography) criteria. The main outcome measures were best corrected visual acuity, retreatment frequency and frequency of side effects.
Results: :
Month-18 data are available for 28 eyes. Visual acuity (VA) was 62 letters at baseline (range: 35-85) and 60 letters at 18 months (23-82), not including one coumarin-treated patient who developed vitreous hemorrhage. VA improved >3 lines in 7% (2/28), stabilized (gain/loss 3 lines in 18% (5/28). Losses of >3 lines were due to vitreous hemorrhage, geographic atrophy and fibrosis. Classic CNV had the best prognosis, with a mean increase of 1.3 letters VA. A mean of 5.1 injections (range: 3-9) were administered in year 1, and 6.0 injections (3-11) over 18 months. Neither systemic side effects nor uveitis were observed. Two patients were lost to follow-up.
Conclusions: :
The combination of same-day PDT and ranibizumab injection stabilized vision and reduced the number of retreatments in this individualized dosing regimen. Eighty-two percent of eyes had stable or improved vision at month 18, despite fewer injections. This combination was well tolerated in all patients.
Clinical Trial: :
www.eudract.emea.europa.eu/index.html
Keywords: age-related macular degeneration • vascular endothelial growth factor • photodynamic therapy