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Functional and anatomical improvements with aflibercept treatment were obtained at week 24 and persisted until week 52.
New data from a recent prospective trial report the significant clinical efficacy and safety profile of aflibercept in the treatment of inflammatory choroidal neovascularization (CNV).
The study suggested that patients obtained both functional and anatomical improvements at week 24 using aflibercept, which continued until the final study visit at week 52.
“At the one-year endpoint, aflibercept treatment demonstrated a mean visual gain of +9.5 letters, associated with a significant decrease in CRT during the same period,” wrote study author Laurent Kodjikian, MD PhD, Department of Ophthalmology, Croix-Rousse University Hospital.
Anti-VEGF injections have replaced other therapies in the treatment of inflammatory CNV, but the rare nature of the disease has led to few retrospective studies reporting on their efficacy and safety in this patient population. Aflibercept has shown non-inferiority to ranibizumab in the treatment of diseases such as exudative AMD and myopic CNV, with investigators expecting similar results when treating CNV.
The ALINEA trial is a prospective, non-comparative, open label trial performed at ophthalmic tertiary retina centers in France in patients aged 18 - 60 years old with a diagnosis of inflammatory CNV. Each patient was treated with 2 mg or intravitreal aflibercept at inclusion and following injections were given as needed, according to the PRN strategy. They were then followed monthly until 52 weeks.
The study included a total of 19 patients, with 18 included in the efficacy analysis after exclusions and then 14 patients included in the primary endpoint analysis. The included patients were majority female (n =14 of 18; 77.8%) and had a mean age of 44.72 years.
At the baseline, investigators reported the mean BCVA and mean central retinal thickness (CRT) were 64.52 letters and 351.79 μm, respectively. Then, at 52 weeks, the mean change in BCVA was +9.50 letters (95% CI, 2.05 – 16.95). The final BCVA reported was 71.93 letters.
Moreover, the mean change in CRT was -62.77 μm at 24 weeks and -66.53 μm at 52 weeks, according to the investigators. The mean total number of injections was reported as 3.56 at 52 weeks. Of the 18 patients, 11 required additional injections after the first mandatory one, with a mean time to retreatment of 64.7 days.
Investigators noted there were no reports of serious ocular adverse events throughout the follow-up period, while a few non-ocular serious adverse events were reported, unrelated to the study drug or protocol.
Kodjikian and colleagues acknowledged the main limitation of the study included the low number of patients, but noted that inflammatory CNV is in fact, a rare condition. They additionally noted that at the time of inclusion there were no other active treatments approved for the disease and it seemed unethical to have a placebo group.
Kodjikian and colleagues added that future studies including phase 3 trials “should confirm these positive outcomes.”
The study, “Efficacy and safety of Aflibercept for the treatment of inflammatory choroidal neovascularization: The ALINEA study,” was published in Acta Ophthalmologica.