Author: Anzhella Fursova (Russian Federation)
Co-authors: Helmut Allmeier, Tobias Machewitz, Daniel Molina
Purpose
The aim of the 24-month AURIGA study is to evaluate the clinical outcomes of intravitreal aflibercept (IVT-AFL) in patients with diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Patients were enrolled from 11 countries, including Russia. The results of the 12-month analysis in treatment-naïve patients with DME who were enrolled in Russia are presented here.
Setting/Venue
AURIGA (NCT03161912) is an ongoing prospective, multicenter, observational study evaluating IVT-AFL in patients with DME or macular edema secondary to RVO. The data below summarize the outcomes for the treatment-naïve cohort of patients with DME in Russia.
Methods
Treatment-naïve patients (aged ≥18 years) with DME were enrolled from April 2018 to August 2020. Decisions regarding IVT-AFL treatment were made at the discretion of the prescribing physician, according to their medical practice. The primary efficacy endpoint was the change in best-corrected visual acuity (BCVA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to Month [M] 12. Secondary endpoints included the change in BCVA from baseline to M6, and, at both M6 and M12, the percentage of study eyes with BCVA gains and losses (≥5, ≥10, and ≥15 letters), change in central retinal thickness (CRT) from baseline, and number of IVT-AFL injections. Safety was also evaluated throughout the study. Patients who received at least 1 IVT-AFL injection and had at least 1 post-initial observation available were included in the full analysis set.
Results
Of 280 treatment-naïve patients (mean age: 61.2 years; female: 73%) enrolled with DME, 66% completed 1 year of treatment. Median duration from DME diagnosis to IVL-AFL treatment was 3.4 months (range: 0.0–148; interquartile range: 0.9–11.2). At M6 and M12, the mean±SD BCVA had improved by +8.6±13.1 and +7.1±13.5 letters, respectively (baseline: 53.6±19.1 letters). The mean number of IVT-AFL injections was 4.4±1.5 by M6 and 5.7±2.6 by M12; 62% (173/280) of patients received ≥5 injections by M6 and 40% (112/280) of patients received ≥7 injections by M12. At M12, 94.1% (254/270) of patients had maintained vision (<15-letter loss), 38.9% (105/270) of patients had gained ≥10 letters, and 28.1% (76/270) of patients had gained ≥15 letters. By M12, the mean CRT had improved by −118.0±143.9 µm (baseline: 441.0±129.6 µm). Ocular treatment-emergent adverse events in the study eye occurred in 2.5% (7/280) of patients; conjunctival hemorrhage was the most common (1.1%[3/280]). There were no reported cases of endophthalmitis or retinal vasculitis; one case of intraocular inflammation was reported.
Conlusions
Treatment-naïve patients with DME who received IVT-AFL treatment in routine clinical practice in Russia achieved clinically relevant improvements in functional and anatomic outcomes that were maintained across the 12-month study period. The mean gain in BCVA at 12 months was +7.1 letters, similar to other observational studies. The majority of patients in this analysis received ≥5 injections in the first 6 months of treatment, and the BCVA gains achieved during this timeframe highlight the importance of intensive treatment to optimize functional outcomes. The safety profile of IVT-AFL was consistent with previous studies. The AURIGA study builds on the wealth of real-world evidence supporting the effectiveness and safety of IVT-AFL as evaluated in 22 published Bayer-sponsored studies in routine clinical practice treating more than 18,000 patients across 24 countries in multiple indications.
Financial Disclosure
Anzhella Fursova: None. Helmut Allmeier: Employee of Bayer Consumer Care AG, Basel, Switzerland. Tobias Machewitz: Employee of Bayer AG, Berlin, Germany. Daniel Molina: Employee of Bayer Consumer Care AG, Basel, Switzerland. Funding: The AURIGA study was funded by Bayer AG, Germany. Medical writing support was provided by ApotheCom, and funded by Bayer Consumer Care AG, Pharmaceuticals, Switzerland.
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