Abstract
Purpose:
To assess the efficacy and safety of intravitreal aflibercept (IVT-AFL) for treating choroidal neovascularization (CNV) due to age-related macular degeneration (AMD) non responsive to ranibizumab therapy.
Methods:
A prospective two-center study of eyes affected by CNV due to AMD and treated with IVT-AFL (2.0 mg) was conducted. Indication for treatment was a failed response to intravitreal ranibizumab therapy, defined as persistent or recurrent subretinal and/or intraretinal fluid on spectral domain optical coherence tomography (SD-OCT) after at least 6 ranibizumab intravitreal injections during the previous 12 months and within 1 month after the last injection. Treatment regimen was based on an initial IVT-AFL injection followed by individualized re-treatment with monthly evaluation of BCVA, fundus biomicroscopy and SD-OCT imaging. The primary efficacy outcome was the change in BCVA. Secondary outcomes include the reduction in central retinal thickness (CRT) and the number of injections required during the follow-up. The incidence of ocular and non-ocular adverse events was recorded. Repeated-measures ANOVAs, with Greenhouse-Geisser correction and a significance level of 5%, were conducted to assess whether there were differences between average values. Serial comparisons of pretreatment and post-treatment outcomes were performed with Dunnett multiple comparisons tests.
Results:
The study included 40 eyes with CNV secondary to AMD. Data from a 3-month follow-up are available for all patients. Eighteen eyes reached 6 months of follow-up. Each patient received a mean of 8 ranibizumab treatments before enrollment. At 3 months mean BCVA (±SD) improvement was 0.07 (±0.2) logMAR (p=0.0003) and CRT (±SD) decreased on average by 163 (±186) μm (p<0.0001). At 6 months visual acuity improved on average by 0.08 (±0.1) logMAR (p=0.0016) and mean reduction in CRT was 156 (±232) µm (p<0.0001). Thirty-four patients (85%) experienced reactivation of CNV lesion 3 months after the first IVT-AFL and required an additional treatment. No significant adverse events were recorded during the follow-up.
Conclusions:
IVT-AFL is a valid treatment option for CNV due to AMD and can offer an effective alternative for lesions not responding to other anti-VEGF therapies.
Keywords: 412 age-related macular degeneration •
453 choroid: neovascularization •
748 vascular endothelial growth factor