Abstract
Purpose To present a cohort of treatment-naive patients with the neovascular form of age-related macular degeneration (nAMD) treated with aflibercept in a fixed regimen and evaluate the treatment response of three types of choroidal neovascular membrane (CNV)—occult (Type 1), classic (Type 2), and minimally classic (Type 4). Methods This was a multicentre, prospective, observational consecutive case series study. Patients diagnosed with three types of CNV of nAMD were treated in a fixed regimen (3 injections every 4 weeks, and then injections at 8 week intervals). The follow-up period was 48 weeks. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts and spectral-domain optical coherence tomography (OCT). The measurements were taken at the baseline and then at 16, 32, and 48 weeks. Results The treatment-naive group was composed of 135 eyes of 135 patients in the study. 61 eyes had Type 1 lesions of CNV, 50 eyes had Type 2 lesions, and 24 eyes had Type 4 lesions. Mean baseline BCVA ± SD for Type 1 lesions was 56.1 ± 10.8 ETDRS letters, and then 62.2 ± 12.9 letters, 61.2 ± 13.7 letters, and 62.8 ± 15.1 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD for Type 1 lesions was 442.4 ± 194.9 μm, and then 302.5 ± 144.4 μm, 299.7 ± 128.5 μm, and 277.7 ± 106.5 μm at 16, 32, and 48 weeks, respectively. Mean baseline BCVA ± SD for Type 2 lesions was 55.6 ± 9.9 ETDRS letters, and then 62.5 ± 11.1 letters, 60.7 ± 13.0 letters, and 62.5 ± 14.2 letters at 16, 32, and 48 weeks, respectively. Mean baseline CRT ± SD. For Type 4 lesions mean baseline BCVA ± SD was 56.7 ± 9.0 ETDRS letters, and then 59.1 ± 10.6 letters, 59.5 ± 11.4 letters, and 59.2 ± 12.6 letters at 16, 32, and 48 weeks respectively. Mean baseline CRT ± SD for Type 4 lesions was 492.1 ± 187.0 μm, and then 333.3 ± 137.5 μm, 354.4 ± 175.0 μm, and 326.7 ± 122.4 μm at 16, 32, and 48 weeks respectively. All these changes were statistically significant (p < 0.005). Conclusions The primary outcome of our study is that the treatment with aflibercept in nAMD patients led to statistically significant improvement in BCVA and to a decrease in CRT throughout the follow-up period in both occult and classic types of CNV. The minimally classic type of CNV demonstrated a poorer functional and anatomical response to treatment.
Highlights
In Type 2 lesions of choroidal neovascular membrane (CNV), the most signi cant change was recorded after the rst three a ibercept injections at the 16th week follow-up and at the end of one-year treatment (+6.9 letters from baseline). e most signi cant change was recorded at the 32th week in Type 4 lesions of CNV (+2.8 letters from baseline). e ratio of patients with improvement in Best-corrected visual acuity (BCVA) was 27.9% for Type 1 lesions, 30.0% for Type 2, and 4.2% for Type 4, and these changes were signi cant in all cases (p < 0.005)
Our study found a distribution of 44.4% with Type 1 lesions, 36.3% with Type 2 lesions, and 17.3% with Type 4 lesions. e predominance of Type 1 CNV in our study correlates with the works of Marsiglia, Jung, and the PERSEUS study. e higher proportion of Type 2 lesions in our study may be allied to our moderate sample size
Based on results of BCVA changes, we can conclude that eyes with Type 4 lesions demonstrated a worse letter gain than eyes with Type 1 and Type 2 lesions, so the CNV type can be a predictor to the change of BCVA after anti-VEGF treatment. e minimally classic form of CNV (Type 4) demonstrated a poorer functional and anatomical response to anti-VEGF treatment due to severe morphological changes of the retina
Summary
Patients at least 50 years of age with treatment-naive, active, nAMD, submacular CNV, less than 12 disk areas with foveal involvement, and evidence of intraretinal fluid and/or subretinal fluid were enrolled for prospective assessment of visual outcomes from baseline to 48 weeks and prospective evaluation of lesion findings using multimodal imaging analysis. Vision criteria for recruitment included Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA between 50 and 80 letters (Snellen 20/ 40–20/200) in the affected eye. Further inclusion criteria were aflibercept application in fixed regimen, i.e., beginning of treatment with three monthly doses, followed by four doses bimonthly during the 48-week follow-up. One exception from the dosing regimen in the follow-up period was tolerated, i.e., the minimum number of injections per followup period was 6. Exclusion criteria were patients with RAP (Type 3 of CNV), polypoidal choroidal vasculopathy (PCV), bilateral nAMD, and other possible causes of decreased BCVA (e.g., cataract progression and other retinal or anterior segment pathologies). Intravitreal injections were administered to all patients under aseptic conditions in the operation room with agreed standards of care used at individual hospital departments
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