The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
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.
one tablet of aspirin 300 mg
One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
CH Annecy Genevois
Annecy, France
CHU Caen
Caen, France
CH métropole Savoie
Chambéry, France
visual acuity (VA) improvement after treatment
Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale
Time frame: 1 month
Tolerance
Number, type and grade of severity of adverse drug reactions
Time frame: 3 months
Proportion of blindness patients after treatment
Blindness is defined according to WHO revised categories of visual impairment, as VA \< 1/20 (\< 20/400 or \> 1.3 log.MAR) or visual field \< 10.
Time frame: 1 month
Visual field
Visual field at 3 months.
Time frame: 3 months
Time course of VA on ETDRS chart or ordinal scale
Time frame: 3 months
Time-to-treatment administration impact on VA evolution.
Mean VA improvement according to the time between onset of sign and treatment administration
Time frame: 1 month
Global disability (modified Rankin scale) after treatment
Time frame: 3 months
Quality of life related to vision (NEI-VFQ-25) after treatment
Time frame: 3 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour
CHD Vendée
La Roche-sur-Yon, France
CH de La Rochelle
La Rochelle, France
CHU
Lyon, France
CHU de Montpellier
Montpellier, France
CHU de Nantes
Nantes, France
CHU de Nice
Nice, France
Fondation Ophtalmologique Rothschild
Paris, France
...and 7 more locations