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
THEIA
1 other identifier
interventional
70
1 country
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jun 2018
Longer than P75 for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 23, 2017
CompletedStudy Start
First participant enrolled
June 8, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 16, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 16, 2024
CompletedJanuary 24, 2024
January 1, 2024
5.6 years
June 20, 2017
January 23, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
Tolerance
3 months
Proportion of blindness patients after treatment
1 month
Visual field
3 months
Time course of VA on ETDRS chart or ordinal scale
3 months
Time-to-treatment administration impact on VA evolution.
1 month
- +2 more secondary outcomes
Study Arms (2)
A : Alteplase
EXPERIMENTALIntravenous injection of Alteplase and one tablet of placebo
B : Acetylsalicylic Acid
ACTIVE COMPARATORone tablet of Acetylsalicylic Acid and one dose of IV placebo
Interventions
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 placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
CH Annecy Genevois
Annecy, France
CHU Caen
Caen, France
CH métropole Savoie
Chambéry, 73000, France
CHD Vendée
La Roche-sur-Yon, 85000, France
CH de La Rochelle
La Rochelle, 17019, France
CHU
Lyon, France
CHU de Montpellier
Montpellier, 34295, France
CHU de Nantes
Nantes, 44093, France
CHU de Nice
Nice, 06001, France
Fondation Ophtalmologique Rothschild
Paris, 75019, France
Ch Perpignan
Perpignan, France
CHU de Rennes
Rennes, 35033, France
CHU Rouen
Rouen, France
CH de Saint Nazaire
Saint-Nazaire, 44606, France
CHU de Toulouse
Toulouse, 31059, France
CHU de Tours
Tours, 37044, France
CH Vannes
Vannes, France
Related Publications (1)
Preterre C, Gaultier A, Obadia M, Vignal C, Mourand I, Plat J, Sablot D, Gaudron M, Rodier G, Godeneche G, Urbanczyk C, Marc G, Massardier E, Adam S, Boulanger M, Marcel S, Mechtouff L, Ronziere T, Calviere L, Godard-Ducceschi S, Barbin L, Lebranchu P, Guillon B; THEIA collaborators. Intravenous alteplase versus oral aspirin for acute central retinal artery occlusion within 4.5 h of severe vision loss (THEIA): a multicentre, double-dummy, patient-blinded and assessor-blinded, randomised, controlled, phase 3 trial. Lancet Neurol. 2025 Nov;24(11):909-919. doi: 10.1016/S1474-4422(25)00308-4.
PMID: 41109232DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Benoit GUILLON, Dr
Nantes University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 23, 2017
Study Start
June 8, 2018
Primary Completion
January 16, 2024
Study Completion
January 16, 2024
Last Updated
January 24, 2024
Record last verified: 2024-01