Central Retinal Artery OcclusionPhase 3THEIANCT03197194
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
A Phase 3 study testing Alteplase and acetylsalicylic acid in people with Central Retinal Artery Occlusion, run by Nantes University Hospital at 17 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Artery Occlusion
- What is being tested?
- Alteplase and acetylsalicylic acid
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 17 sitesFrance
- Study dates
- 8 Jun 2018to 16 Jan 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Pregnant or lactating women
- Minors
- Adults under guardianship or trusteeship
- Any contraindication to alteplase
- Any contraindication to aspirin
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
France17 sites
CH Annecy Genevois
Annecy
CHU Caen
Caen
CH métropole Savoie
Chambéry, 73000
CHD Vendée
La Roche-sur-Yon, 85000
CH de La Rochelle
La Rochelle, 17019
CHU
Lyon
CHU de Montpellier
Montpellier, 34295
CHU de Nantes
Nantes, 44093
CHU de Nice
Nice, 06001
Fondation Ophtalmologique Rothschild
Paris, 75019
Ch Perpignan
Perpignan
CHU de Rennes
Rennes, 35033
CHU Rouen
Rouen
CH de Saint Nazaire
Saint-Nazaire, 44606
CHU de Toulouse
Toulouse, 31059
CHU de Tours
Tours, 37044
CH Vannes
Vannes
About this study
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.
- Conditions
- Central Retinal Artery Occlusion
- Being tested
- Alteplase, acetylsalicylic acid, Placebo Oral Tablet, placebo IV
- Keywords
- Central retinal artery occlusion, visual acuity, visual field, mRs, NEI-VFQ-25
- Medical subject headings
- Retinal Artery Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlteplaseDrug
Also called Actilyse
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 acidDrug
Also called Aspirin
one tablet of aspirin 300 mg
Placebo Oral TabletDrug
Also called Placebo aspirin
One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
placebo IVDrug
Also called Placebo Actilyse
IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour
| Study group | Role | What they receive |
|---|---|---|
| A : Alteplase | Experimental | Intravenous injection of Alteplase and one tablet of placebo Receives: Drug: Alteplase; Drug: Placebo Oral Tablet |
| B : Acetylsalicylic Acid | Active comparator | one tablet of Acetylsalicylic Acid and one dose of IV placebo Receives: Drug: acetylsalicylic acid; Drug: placebo IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (7)
Tolerance
Number, type and grade of severity of adverse drug reactions
Measured: 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.
Measured: 1 month
Visual field
Visual field at 3 months.
Measured: 3 months
Time course of VA on ETDRS chart or ordinal scale
Measured: 3 months
Time-to-treatment administration impact on VA evolution.
Mean VA improvement according to the time between onset of sign and treatment administration
Measured: 1 month
Global disability (modified Rankin scale) after treatment
Measured: 3 months
Quality of life related to vision (NEI-VFQ-25) after treatment
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start8 Jun 2018
- Primary completion16 Jan 2024
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Central Retinal Artery OcclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit GUILLON, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03197194
- Sponsor's protocol ID
- RC17_0061
- Acronym
- THEIA
- Status last verified
- Jan 2024
- First submitted
- 20 Jun 2017
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 41109232Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24.
PubMed 39614619
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03197194
- Acronym / sponsor ID
- THEIA / RC17_0061
- Conditions
- Central Retinal Artery Occlusion
- Keywords
- Central retinal artery occlusion, visual acuity, visual field, mRs, NEI-VFQ-25
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 8 Jun 2018 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A : Alteplase | Experimental | Drug: Alteplase, Drug: Placebo Oral TabletIntravenous injection of Alteplase and one tablet of placebo |
| B : Acetylsalicylic Acid | Active comparator | Drug: acetylsalicylic acid, Drug: placebo IVone tablet of Acetylsalicylic Acid and one dose of IV placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AlteplaseAlso: Actilysealteplase 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. | Drug | A : Alteplase |
| acetylsalicylic acidAlso: Aspirinone tablet of aspirin 300 mg | Drug | B : Acetylsalicylic Acid |
| Placebo Oral TabletAlso: Placebo aspirinOne placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid | Drug | A : Alteplase |
| placebo IVAlso: Placebo ActilyseIV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour | Drug | B : Acetylsalicylic Acid |
Primary outcome
visual acuity (VA) improvement after treatment
Time frame: 1 month
Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale
7 secondary outcomes
Tolerance
Time frame: 3 months
Proportion of blindness patients after treatment
Time frame: 1 month
Visual field
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
- Derived from this study: PubMed 41109232Preterre 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.
- Derived from this study: PubMed 39614619Abdelmassih Y, Mauget-Faysse M, Seners P, Milea D, Hallali G, Guillaume J, Lecler A, Vignal C, Le Mer Y, Paques M, Bonnin S, Obadia M. Early reperfusion in patients with acute retinal artery occlusion: A multicenter prospective study. Int J Stroke. 2025 Mar;20(3):338-346. doi: 10.1177/17474930241306692. Epub 2024 Dec 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoit GUILLON, Dr principal investigator
Nantes University Hospital
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alteplase and acetylsalicylic acid in people with Central Retinal Artery Occlusion, run by Nantes University Hospital at 17 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (VA) improvement after treatment (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03197194, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.