Abstract Body: Introduction and Hypothesis : Central retinal artery occlusion (CRAO) is a severe disease with more than 85% of patients retaining monocular blindness, and a high risk of further ischemic events. Although open label studies and meta-analyses have suggested that early revascularization of the retina with intravenous-thrombolysis within 4.5 hours of vision loss is associated with improved visual recovery in acute CRAO, there is currently no level 1 evidence to support this treatment. Three randomized clinical trials (RTC) are ongoing in Europe (France, Germany, Norway), and we will present the results of the French THEIA study, which is the first RCT to assess intravenous-alteplase in CRAO patients within 4.5hours of vision loss onset.
Methods: THEIA (THrombolysis in acute cEntral retInal Artery occlusion) is a phase-III, randomised, single blind, double-dummy multicenter study evaluating the efficacy/safety of IV-alteplase versus aspirin in acute CRAO. Patients ≥18 yo with acute CRAO and severe vision loss (best-corrected visual acuity (BCVA) worse than <20/400 [>1.3LogMAR]) and no contraindication to IV-alteplase or aspirin were randomized in a 1:1 ratio to receive IV-alteplase 0.9mg/kg over 1hr or aspirin (300mg), within 4.5hours of symptom onset. Primary outcome was improvement of BCVA of 15 letters (0.3Log.Mar VA) or more on the ETDRS-VA chart (increase of ≥3 lines) between baseline and 1month. Main secondary outcomes were safety (focused on intracranial bleeding), functional recovery defined by VA ≤Log-Mar0.5 (able to read with affected eye), quality of life (modified Rankin Scale/NEI-VFQ-25). ClinicalTrials.gov:NCT03197194.
Results: 70 patients were randomized (mean age 70.2±9; 36% women) ; mean BCVA at baseline was 2.3LogMAR (94% were off-chart). Mean onset-to-needle time was 232min. There was no safety warning from the DSMB. Lock database occurred in June 2024 and data analysis is still ongoing.
Conclusions: The final results of the THEIA study will be available in February 2025 for presentation at the ISC, with emphasis on implications for patient care networks.