Author: Audrey Giocanti-Aurégan (France)
Co-authors: Laurent Velasque, Sylvia Nghiem Buffet, Maté Streho, Helmut Allmeier, Tobias Machewitz, Kay D. Rittenhouse
Purpose
The aim of the 24-month AURIGA study is to evaluate the clinical outcomes of intravitreal aflibercept (IVT-AFL) in patients with macular edema secondary to retinal vein occlusion (RVO) or diabetic macular edema (DME) in routine clinical practice. Patients were enrolled from 11 countries, including France. The results of the 12-month analysis in treatment-naïve patients with macular edema secondary to RVO who were enrolled in France are presented here.
Setting/Venue
AURIGA (NCT03161912) is an ongoing, prospective, multicenter, observational study evaluating IVT-AFL in patients with macular edema secondary to RVO or DME. This analysis summarizes the outcomes for the treatment-naïve cohort of patients with RVO in France.
Methods
Treatment-naïve patients (aged ≥18 years) with macular edema secondary to RVO (central RVO [CRVO] and branch RVO [BRVO; also including patients with hemicentral RVO]) were enrolled from April 2018 to January 2019. Decisions regarding IVT-AFL treatment were made at the discretion of the prescribing physician, according to their medical practice. The primary 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 proportion of study eyes with BCVA gains and losses (≥5, ≥10, and ≥15 letters), change in central retinal thickness (CRT) from baseline, number of IVT-AFL injections, mean duration of treatment intervals, and proportion of patients with macular edema on optical coherence tomography. Safety was also evaluated throughout the study. Patients who received at least one IVT-AFL injection and had at least one post-initial observation available were included in the full analysis set.
Results
Of 138 treatment-naïve patients (mean age: 67.7 years; female: 50%; CRVO: n=62; BRVO: n=76), 76% (105/138 patients) completed 1 year of treatment. Overall median duration from diagnosis to IVT-AFL treatment was 0.3 months (range 0–53.5). By M12, mean improvements in BCVA (95% CI) were +13.6 (7.8, 19.3) and +14.6 (11.5, 17.6) letters in CRVO and BRVO patients, respectively (baseline±SD: 41.1±24.1 and 60.6±14.5); 98% of all patients had BCVA decreases <15 letters and 46% had BCVA improvements ≥15 letters. At M12, mean CRT decreased by ‒324.6 (‒388.5, ‒260.8) μm (CRVO; baseline: 672.9±199.7), and ‒232.7 (‒271.3, ‒194.1) μm (BRVO; baseline: 522.8±157.9). The proportion of RVO patients with macular edema decreased from 90% at baseline to 33% at M12. The mean number of IVT-AFL injections was 4.4±1.2 by M6 and 6.6±2.6 by M12 (53% received ≥5 injections by M6; 52% received ≥7 injections by M12). By M12, the last completed treatment interval (for patients who received ≥2 IVT-AFL injections) was ≥10 weeks in 31% (CRVO) and 65% (BRVO) of patients and ≥12 weeks in 21% (CRVO) and 50% (BRVO). Adverse events were consistent with the known safety profile of IVT-AFL. No cases of intraocular inflammation, retinal vasculitis, or endophthalmitis were reported.
Conlusions
In treatment-naïve patients with macular edema secondary to RVO in the AURIGA study, 12-month treatment with IVT-AFL was associated with functional and anatomic improvements in routine clinical practice in France. The magnitude of BCVA gain and CRT improvement at 12 months was comparable to that achieved in interventional studies. No new safety findings were identified. 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
Audrey Giocanti-Aurégan: Clinical investigator: Bayer Sylvia Nghiem Buffet: Clinical investigator: Bayer Maté Streho: Consultant: Alcon, Bayer, Novartis, and Quantel Medical Laurent Velasque: Consultant: Alcon, Bayer, and Novartis; Clinical investigator: Bayer Agnès Glacet-Bernard: Clinical investigator: Bayer Helmut Allmeier: Employee: Bayer Consumer Care AG, Basel, Switzerland Tobias Machewitz: Employee: Bayer AG, Berlin, Germany Kay D. Rittenhouse: Employee: 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.
Comments
Important add below co-authors: 7. - Agnès Glacet-Bernard: Intercommunal Hospital Center and Henri Mondor Hospital, Paris-Est Créteil University (UPEC, Paris XII University), Paris, France
