Central Retinal Artery OcclusionPhase 3REVISIONNCT04965038

Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion

A Phase 3 study testing Tenecteplase (until trial protocol V04: Alteplase) in people with Central Retinal Artery Occlusion, run by University Hospital Tuebingen at 1 site in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. 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?: Tenecteplase (until trial protocol V04: Alteplase)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: 1 siteGermany
Study dates: 10 Oct 2022to 29 Apr 2026
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

Acute non-arteritic CRAO (i.e. sudden, painless monocular vision loss) ≤ 12 hours after symptom onset confirmed by an experienced ophthalmologist through assessment of: BCVA, intraocular pressure, swinging flash light test (relative afferent pupil defect), slit-lamp biomicroscopy, fundoscopy, and OCT of the macula of both eyes* (*within the 4.5-hour time window: to be skipped if not feasible ≤ 10 minutes; beyond the 4.5-hour time window: mandatory)
BCVA of LogMAR ≥ 1.3 in the affected eye (functional blindness according to WHO ICD-11)
Reading must have been possible with the affected eye before CRAO (LogMAR ≤ 0.5)
Neurological examination performed by an experienced stroke neurologist
Brain imaging as per local standard for acute retinal ischemia/stroke assessment, either cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI)

Who cannot join

Suspected giant cell arteritis
Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreous hemorrhage, acute glaucoma, acute optic neuritis)
BCVA of LogMAR < 1.3 or rapidly improving vision in the affected eye
Acute ischemic stroke with indication for on-label intravenous thrombolysis (IVT)
Any co-existing or terminal disease with anticipated life expectancy of < 3 months
Prior participation in the REVISION trial

Trial locations and contacts

1 site in 1 country.

Germany1 site

University Hospital Tuebingen
Tübingen, 72076

Other trials in Germany

About this study

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION randomized placebo-controlled interventional trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset.

The REVISION observational study will evaluate retinal changes on optical coherence tomography (OCT) in patients within 12 hours of CRAO onset, and the REVISION substudy, which will be conducted adjunct to either the interventional or the observational study, will evaluate the value of the retrobulbar spot sign for prediction of outcome and treatment response.

Read the detailed description

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss in the affected eye in ~ 95% of cases. Despite a variety of widely practiced "conservative standard treatments", such as hemodilution, ocular massage, and paracentesis, there is no evidence-based therapy for non-arteritic CRAO. Animal models have proven a limited ischemic tolerance of the retina with irreversible damage occurring within only four hours after disruption of blood flow. This is why rapid reperfusion represents THE logical therapeutic approach. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset.

Sequential evaluation by optical coherence tomography (OCT) will visualize dynamic ischemic changes of the retina during and after CRAO. The REVISION observational study will enroll patients within 12 hours of symptom onset and aims at comparing late time window retinal findings to early ischemic changes found in patients of the randomized REVISION interventional trial. Ultimately, OCT may become the preferred tool when it comes to assess retinal tissue viability in patients with an unknown CRAO onset (e.g. wake-up CRAO), and CRAO patients who present in an extended time window beyond 4.5 hours.

The REVISION substudy, which will be conducted adjunct to either the interventional or the observational study, will evaluate the value of the retrobulbar spot sign for prediction of outcome and treatment response.

Conditions: Central Retinal Artery Occlusion
Being tested: Tenecteplase (until trial protocol V04: Alteplase)
Keywords: Central Retinal Artery Occlusion, Thrombolysis, Alteplase
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.

Tenecteplase (until trial protocol V04: Alteplase)Drug
Intravenous thrombolysis within 4.5 hours of symptom onset

Study groups in NCT04965038
Study group	Role	What they receive
Thrombolysis (interventional study)	Active comparator	Tenecteplase (0.25 mg per kg body weight as bolus; until trial protocol V04: Alteplase [0.9 mg per kg body weight; 10% as bolus; remaining over one hour] will be administered intravenously within 4.5 hours of symptom onset Receives: Drug: Tenecteplase (until trial protocol V04: Alteplase)
Placebo (interventional study)	Placebo comparator	Placebo (0.25 mg per kg body weight as bolus; until trial protocol V04: 0.9 mg per kg body weight; 10% as bolus; remaining over one hour) will be administered intravenously within 4.5 hours of symptom onset Receives: Drug: Tenecteplase (until trial protocol V04: Alteplase)
Observational study	No intervention	The prospective REVISION observational study will enroll patients within 12 hours of symptom onset

What is being measured

The primary outcome is the main question the study is designed to answer.

Functional recovery at visit 3
Functional recovery to best corrected visual acuity of logarithm of the minimum angle of resolution ≤ 0.5 in the affected eye, which corresponds to normal to mild vision impairment (intention-to-treat analysis).
Measured: 30 days

Secondary outcomes (17)

best corrected visual acuity (BCVA) at visits 2, 3, and 4
Functional recovery to best corrected visual acuity of logarithm of the minimum angle of resolution ≤ 0.5 in the affected eye, which corresponds to normal to mild vision impairment (intention-to-treat and per-protocol analyses).
Measured: 90 days
Shift in visual outcome categories at visits 2, 3, and 4
Shift in visual outcome categories: normal vision (logarithm of the minimum angle of resolution (LogMAR) ≤ 0), mild vision impairment (LogMAR > 0 and ≤ 0.5), moderate vision impairment (LogMAR > 0.5 and ≤ 1.0), severe vision impairment (LogMAR > 1.0 and ≤ 1.3), counting fingers (LogMAR > 1.3 and ≤ counting fingers), hand motion or light perception, and no light perception.
Measured: 90 days
Dichotomized analysis of visual outcome at visits 2, 3, and 4
Dichotomized analysis of visual outcome: 'normal vision to moderate vision impairment' vs. 'severe vision impairment or functional blindness' and 'normal vision to severe vision impairment' vs. 'functional blindness'.
Measured: 90 days
Visual field at visits 3 and 4
Kinetic visual field using III4e mark
Measured: 90 days
Central retinal artery recanalization at visits 2, 3, and 4
Central retinal artery recanalization assessed using optical coherence tomography angiography (OCTA) of the optic nerve head and the macula.
Measured: 90 days
Retinal arterial perfusion at visits 3 and 4
Retinal arterial perfusion assessed using fluorescein angiography.
Measured: 90 days
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) at visits 3 and 4
NEI-VFQ-25 for assessment of relevant visual impairment
Measured: 90 days
National Institutes of Health Stroke Scale (NIHSS) score at visit 2
NIHSS for assessment of neurological deficits due to ischemic stroke or intracranial hemorrhage
Measured: 72 hours
Modified Rankin Scale (mRS) score at visits 3 and 4
Dichotomized analysis and shift analyses of mRS (categories 0 - 1 (excellent outcome) vs. 2 - 6, 0 - 2 (functional independence) vs. 3 - 6, 0 - 3 (walking) vs. 4 - 6, and 0 - 4 vs. 5 - 6 (bedridden or death), and shift analysis)
Measured: 90 days
Fresh ischemic lesions on cranial magnetic resonance imaging (MRI) at visit 2
Fraction of patients with and number of acute ischemic lesions on follow-up diffusion-weighted cranial MRI
Measured: 72 hours
Death at visits 3 and 4
All-cause and stroke-related death
Measured: 90 days
Any intracranial hemorrhage (ICH) at visit 2
Any ICH (except microhemorrhages) on follow-up magnetic resonance imaging; in case of missing follow-up brain imaging due to premature death, ICH will be replaced by "ICH or death without repeat scan")
Measured: 72 hours
Symptomatic intracranial hemorrhage (ICH) until visit 2
Symptomatic ICH (as per ECASS III and Heidelberg bleeding classification) until follow-up magnetic resonance imaging; in case of missing follow-up brain imaging due to premature death, symptomatic ICH will be replaced by "symptomatic ICH or death without repeat scan")
Measured: 72 hours
Intraocular hemorrhage in the affected eye at visit 2
Intraocular hemorrhage in the affected eye
Measured: 72 hours
Major bleeding until visit 2
Major bleeding, defined as clinically overt bleeding associated with at least one of the following features: decrease in hemoglobin levels of ≥ 2 g/dL over 24 hours, bleeding requiring transfusion of ≥ 2 units of packed red cells, bleeding at a critical site (i.e., intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, or retroperitoneal), or bleeding resulting in the death of the patient
Measured: 72 hours
Retinal neovascularization requiring therapy at visit 3 and 4
Retinal neovascularization requiring therapy
Measured: 90 days
(Serious) adverse events ((S)AE)
AE until visit 2, serious AE and AE of special interest until visit 3 and 4
Measured: 90 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202229 Apr 2026

First posted16 Jul 2021
Study start10 Oct 2022
Primary completion23 Mar 2026
Study completion29 Apr 2026

Why it stopped: Stopped after prespecified interim analysis due to futility

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.
More trials run by University Hospital TuebingenThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04965038
Sponsor's protocol ID: 2021-000183-29
Acronym: REVISION
Status last verified: Apr 2026
First submitted: 15 Jun 2021
Last updated: 18 May 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Poli S, Grohmann C, Wenzel DA, Poli K, Tunnerhoff J, Nedelmann M, Fiehler J, Burghaus I, Lehmann M, Glauch M, Schadwinkel HM, Kalmbach P, Zeller J, Peters T, Eschenfelder C, Agostini H, Campbell BC, Fischer MD, Sykora M, Mac Grory B, Feltgen N, Kowarik M, Seiffge D, Strbian D, Albrecht M, Alzureiqi MS, Auffarth G, Bazner H, Behnke S, Berberich A, Bode F, Bohmann FO, Cheng B, Czihal M, Danyel LA, Dimopoulos S, Pinhal Ferreira de Pinho JD, Fries FN, Gamulescu MA, Gekeler F, Gomez-Exposito A, Gumbinger C, Guthoff R, Hattenbach LO, Kellert L, Khoramnia R, Kohnen T, Kurten D, Lackner B, Laible M, Lee JI, Leithner C, Liegl R, Lochner P, Mackert M, Mbroh J, Muller S, Nagel S, Prasuhn M, Purrucker J, Reich A, Mundiyanapurath S, Royl G, Salchow DJ, Schafer JH, Schlachetzki F, Schmack I, Thomalla G, Tieck Fernandez MP, Wakili P, Walter P, Wolf A, Wolf M, Bartz-Schmidt KU, Schultheiss M, Spitzer MS. Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial. Int J Stroke. 2024 Aug;19(7):823-829. doi: 10.1177/17474930241248516. Epub 2024 Jun 25.
PubMed 38591748
Mac Grory B, Preterre C, Lebranchu P, Ryan SJ, Jorstad OK, Moe MC, Tunnerhoff J, Spitzer MS, Grohmann C, Dumitrascu OM, Biousse V, Guillon B, Aamodt AH, Poli S, Schrag M; Central Retinal ArterY OcclusioN (CRAYON) Collaborators. Intravenous thrombolysis for acute central retinal artery occlusion: Protocol for a systematic review and individual participant data meta-analysis of randomized controlled trials. PLoS One. 2026 Mar 10;21(3):e0342739. doi: 10.1371/journal.pone.0342739. eCollection 2026.
PubMed 41805966

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Central Retinal Artery Occlusion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Early Reperfusion Therapy With Intravenous Thrombolysis for Recovery of VISION in Acute Central Retinal Artery Occlusion
ClinicalTrials.gov ID: NCT04965038
Acronym / sponsor ID: REVISION / 2021-000183-29
Conditions: Central Retinal Artery Occlusion
Keywords: Central Retinal Artery Occlusion, Thrombolysis, Alteplase
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Stopped after prespecified interim analysis due to futility
Enrolment: 127 participants (actual)
Lead sponsor: University Hospital TuebingenUniversity, hospital or other
Study start: 10 Oct 2022 (actual)
Primary completion: 23 Mar 2026 (actual)
Study completion: 29 Apr 2026 (actual)
First posted: 16 Jul 2021 (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.

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss; no evidence-based therapy does exist. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION randomized placebo-controlled interventional trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset.

Detailed description

Non-arteritic, thromboembolic central retinal artery occlusion (CRAO) is an acute neurovascular-ophthalmological emergency which leads to severe and permanent vision loss in the affected eye in ~ 95% of cases. Despite a variety of widely practiced "conservative standard treatments", such as hemodilution, ocular massage, and paracentesis, there is no evidence-based therapy for non-arteritic CRAO. Animal models have proven a limited ischemic tolerance of the retina with irreversible damage occurring within only four hours after disruption of blood flow. This is why rapid reperfusion represents THE logical therapeutic approach. Two recent meta-analyses indicate early intravenous thrombolysis to be beneficial in CRAO. Therefore, the REVISION trial will investigate intravenous alteplase in CRAO as it is practiced in acute ischemic stroke, i.e. within 4.5 hours after symptom onset.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Thrombolysis (interventional study)	Active comparator	Drug: Tenecteplase (until trial protocol V04: Alteplase)Tenecteplase (0.25 mg per kg body weight as bolus; until trial protocol V04: Alteplase [0.9 mg per kg body weight; 10% as bolus; remaining over one hour] will be administered intravenously within 4.5 hours of symptom onset
Placebo (interventional study)	Placebo comparator	Drug: Tenecteplase (until trial protocol V04: Alteplase)Placebo (0.25 mg per kg body weight as bolus; until trial protocol V04: 0.9 mg per kg body weight; 10% as bolus; remaining over one hour) will be administered intravenously within 4.5 hours of symptom onset
Observational study	No intervention	–The prospective REVISION observational study will enroll patients within 12 hours of symptom onset

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Acute non-arteritic CRAO (i.e. sudden, painless monocular vision loss) ≤ 12 hours after symptom onset confirmed by an experienced ophthalmologist through assessment of: BCVA, intraocular pressure, swinging flash light test (relative afferent pupil defect), slit-lamp biomicroscopy, fundoscopy, and OCT of the macula of both eyes* (*within the 4.5-hour time window: to be skipped if not feasible ≤ 10 minutes; beyond the 4.5-hour time window: mandatory)
BCVA of LogMAR ≥ 1.3 in the affected eye (functional blindness according to WHO ICD-11)
Reading must have been possible with the affected eye before CRAO (LogMAR ≤ 0.5)
Neurological examination performed by an experienced stroke neurologist
Brain imaging as per local standard for acute retinal ischemia/stroke assessment, either cranial computed tomography (CT) or cranial magnetic resonance imaging (MRI)

Key exclusion criteria (6 listed)

Suspected giant cell arteritis
Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreous hemorrhage, acute glaucoma, acute optic neuritis)
BCVA of LogMAR < 1.3 or rapidly improving vision in the affected eye
Acute ischemic stroke with indication for on-label intravenous thrombolysis (IVT)
Any co-existing or terminal disease with anticipated life expectancy of < 3 months

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
Tenecteplase (until trial protocol V04: Alteplase)Intravenous thrombolysis within 4.5 hours of symptom onset	Drug	Placebo (interventional study), Thrombolysis (interventional study)

Primary outcome

Functional recovery at visit 3
Time frame: 30 days
Functional recovery to best corrected visual acuity of logarithm of the minimum angle of resolution ≤ 0.5 in the affected eye, which corresponds to normal to mild vision impairment (intention-to-treat analysis).

17 secondary outcomes

best corrected visual acuity (BCVA) at visits 2, 3, and 4
Time frame: 90 days
Shift in visual outcome categories at visits 2, 3, and 4
Time frame: 90 days
Dichotomized analysis of visual outcome at visits 2, 3, and 4
Time frame: 90 days
Visual field at visits 3 and 4
Time frame: 90 days
Central retinal artery recanalization at visits 2, 3, and 4
Time frame: 90 days
Retinal arterial perfusion at visits 3 and 4
Time frame: 90 days
National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) at visits 3 and 4
Time frame: 90 days
National Institutes of Health Stroke Scale (NIHSS) score at visit 2
Time frame: 72 hours
Modified Rankin Scale (mRS) score at visits 3 and 4
Time frame: 90 days
Fresh ischemic lesions on cranial magnetic resonance imaging (MRI) at visit 2
Time frame: 72 hours
Death at visits 3 and 4
Time frame: 90 days
Any intracranial hemorrhage (ICH) at visit 2
Time frame: 72 hours
Symptomatic intracranial hemorrhage (ICH) until visit 2
Time frame: 72 hours
Intraocular hemorrhage in the affected eye at visit 2
Time frame: 72 hours
Major bleeding until visit 2
Time frame: 72 hours
Retinal neovascularization requiring therapy at visit 3 and 4
Time frame: 90 days
(Serious) adverse events ((S)AE)
Time frame: 90 days

Results and safety

The study was stopped early (reason given: Stopped after prespecified interim analysis due to futility). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Background: PubMed 38591748Poli S, Grohmann C, Wenzel DA, Poli K, Tunnerhoff J, Nedelmann M, Fiehler J, Burghaus I, Lehmann M, Glauch M, Schadwinkel HM, Kalmbach P, Zeller J, Peters T, Eschenfelder C, Agostini H, Campbell BC, Fischer MD, Sykora M, Mac Grory B, Feltgen N, Kowarik M, Seiffge D, Strbian D, Albrecht M, Alzureiqi MS, Auffarth G, Bazner H, Behnke S, Berberich A, Bode F, Bohmann FO, Cheng B, Czihal M, Danyel LA, Dimopoulos S, Pinhal Ferreira de Pinho JD, Fries FN, Gamulescu MA, Gekeler F, Gomez-Exposito A, Gumbinger C, Guthoff R, Hattenbach LO, Kellert L, Khoramnia R, Kohnen T, Kurten D, Lackner B, Laible M, Lee JI, Leithner C, Liegl R, Lochner P, Mackert M, Mbroh J, Muller S, Nagel S, Prasuhn M, Purrucker J, Reich A, Mundiyanapurath S, Royl G, Salchow DJ, Schafer JH, Schlachetzki F, Schmack I, Thomalla G, Tieck Fernandez MP, Wakili P, Walter P, Wolf A, Wolf M, Bartz-Schmidt KU, Schultheiss M, Spitzer MS. Early REperfusion therapy with intravenous alteplase for recovery of VISION in acute central retinal artery occlusion (REVISION): Study protocol of a phase III trial. Int J Stroke. 2024 Aug;19(7):823-829. doi: 10.1177/17474930241248516. Epub 2024 Jun 25.
Background: PubMed 41805966Mac Grory B, Preterre C, Lebranchu P, Ryan SJ, Jorstad OK, Moe MC, Tunnerhoff J, Spitzer MS, Grohmann C, Dumitrascu OM, Biousse V, Guillon B, Aamodt AH, Poli S, Schrag M; Central Retinal ArterY OcclusioN (CRAYON) Collaborators. Intravenous thrombolysis for acute central retinal artery occlusion: Protocol for a systematic review and individual participant data meta-analysis of randomized controlled trials. PLoS One. 2026 Mar 10;21(3):e0342739. doi: 10.1371/journal.pone.0342739. eCollection 2026.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Central Retinal Artery Occlusion

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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tenecteplase (until trial protocol V04: Alteplase) in people with Central Retinal Artery Occlusion, run by University Hospital Tuebingen at 1 site in Germany.

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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Stopped after prespecified interim analysis due to futility). Results are not available in the source record.

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?

Functional recovery at visit 3 (time frame: 30 days). 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 NCT04965038, 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 18 May 2026.