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

Central Retinal Artery Occlusion Clinical Trial

— THEIA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03197194
• Other study ID #: RC17_0061
• Status: Completed
• Phase: Phase 3
• 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
• 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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Central Retinal Artery Occlusion
• Retinal Artery Occlusion

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