A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion

PHASE3CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

June 8, 2018

Primary Completion Date

January 16, 2024

Study Completion Date

January 16, 2024

Conditions
Central Retinal Artery Occlusion
Interventions
DRUG

Alteplase

alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour.

DRUG

acetylsalicylic acid

one tablet of aspirin 300 mg

DRUG

Placebo Oral Tablet

One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid

DRUG

placebo IV

IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour

Trial Locations (17)

17019

CH de La Rochelle, La Rochelle

31059

CHU de Toulouse, Toulouse

34295

CHU de Montpellier, Montpellier

35033

CHU de Rennes, Rennes

37044

CHU de Tours, Tours

44093

CHU de Nantes, Nantes

44606

CH de Saint Nazaire, Saint-Nazaire

73000

CH métropole Savoie, Chambéry

75019

Fondation Ophtalmologique Rothschild, Paris

85000

CHD Vendée, La Roche-sur-Yon

Unknown

CH Annecy Genevois, Annecy

CHU Caen, Caen

CHU, Lyon

Ch Perpignan, Perpignan

CHU Rouen, Rouen

CH Vannes, Vannes

06001

CHU de Nice, Nice

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT03197194 - A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion | Biotech Hunter | Biotech Hunter