EAGLE - Multicenter Study of the European Assessment Group for Lysis in the Eye "EAGLE"

Terminated

Phase 3 Results N/A

Trial Description

The aim of the EAGLE Study is to compare the efficacy of conservative medical treatment and local intraarterial fibrinolysis in patients with central retinal artery occlusion and to evaluate benefit and risk for the patient of both therapies.

Trial Stopped: Due to results of conditional power analysis performed at the first interim analysis and due to observed spectrum of adverse events.

Conditions

Interventions

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Visual acuity 1 month after therapy in comparison with visual acuity before therapy measured according to ETDRS Scale. 1 month No
Secondary Improvement of visual field 1 month No
Secondary Effect on retinal circulation 1 month No
Secondary Tolerance of therapies and registration of number, form and severity of complications 1 month Yes
Secondary Evaluation of prognostic factors No

Sponsors