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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03197194
Other study ID # RC17_0061
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 8, 2018
Est. completion date January 16, 2024

Study information

Verified date January 2024
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date January 16, 2024
Est. primary completion date January 16, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients aged up to 18 years - CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist. - Blindness defined according to WHO classification as visual acuity <1/20 (20/400). - Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset. - No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis - No clinical or radiological evidence of stroke within the last 3 months. - Patients covered by health care insurance (social security) - Written informed consent obtained. Exclusion Criteria: - Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset. - Minor VA deficit or VA rapidly improving before start of infusion. - CRAO without foveal ischemia. - Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy. - Clinical or laboratory evidence of temporal arteritis. - Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI. - Pregnant or lactating women - Minors - Adults under guardianship or trusteeship - Any contraindication to alteplase - Any contraindication to aspirin

Study Design


Intervention

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.
acetylsalicylic acid
one tablet of aspirin 300 mg
Placebo Oral Tablet
One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
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

Locations

Country Name City State
France CH Annecy Genevois Annecy
France CHU Caen Caen
France CH métropole Savoie Chambéry
France 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 Ch Perpignan Perpignan
France CHU de Rennes Rennes
France CHU Rouen Rouen
France CH de Saint Nazaire Saint-Nazaire
France CHU de Toulouse Toulouse
France CHU de Tours Tours
France CH Vannes Vannes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 month
Secondary Tolerance Number, type and grade of severity of adverse drug reactions 3 months
Secondary 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. 1 month
Secondary Visual field Visual field at 3 months. 3 months
Secondary Time course of VA on ETDRS chart or ordinal scale 3 months
Secondary Time-to-treatment administration impact on VA evolution. Mean VA improvement according to the time between onset of sign and treatment administration 1 month
Secondary Global disability (modified Rankin scale) after treatment 3 months
Secondary Quality of life related to vision (NEI-VFQ-25) after treatment 3 months
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