Clinical trial 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Central Retinal Artery Occlusion
Keywords: Central retinal artery occlusion
visual acuity
visual field
mRs
NEI-VFQ-25
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2017-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: visual acuity (VA) improvement after treatment
timeFrame: 1 month
Secondary outcomes:
measure: Tolerance
timeFrame: 3 months
measure: Proportion of blindness patients after treatment
timeFrame: 1 month
measure: Visual field
timeFrame: 3 months
measure: Time course of VA on ETDRS chart or ordinal scale
timeFrame: 3 months
measure: Time-to-treatment administration impact on VA evolution.
timeFrame: 1 month
measure: Global disability (modified Rankin scale) after treatment
timeFrame: 3 months
measure: Quality of life related to vision (NEI-VFQ-25) after treatment
timeFrame: 3 months
Other outcomes:
Locations:
city: Annecy
country: France
facility: CH Annecy Genevois
city: Caen
country: France
facility: CHU Caen
city: Chambéry
country: France
facility: CH métropole Savoie
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: CH de La Rochelle
city: Lyon
country: France
facility: CHU
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Paris
country: France
facility: Fondation Ophtalmologique Rothschild
city: Perpignan
country: France
facility: Ch Perpignan
city: Rennes
country: France
facility: CHU de Rennes
city: Rouen
country: France
facility: CHU Rouen
city: Saint-Nazaire
country: France
facility: CH de Saint Nazaire
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Vannes
country: France
facility: CH Vannes
Study officials:
affiliation: Nantes University Hospital
name: Benoit GUILLON, Dr
role: PRINCIPAL_INVESTIGATOR
References: