Central Retinal Artery OcclusionPhase 3TenCRAOSNCT04526951
TENecteplase in Central Retinal Artery Occlusion Stuy (TenCRAOS)
A Phase 3 study of Central Retinal Artery Occlusion, run by Oslo University Hospital at 18 sites in 6 countries.
Trial summary
TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Retinal Artery Occlusion
- 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
- 81 participants
- Where
- 18 sitesin 6 countries
- Study dates
- 30 Oct 2020to 20 Jun 2025
- 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
- Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours.
- Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
- Age ≥18 years.
- Informed written consent of the patient.
- A woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given.
Who cannot join
- Other active intervention targeting CRAO.
- Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception).
- Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
- Presence of intracranial haemorrhage on brain MRI/CT.
- Medical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
- No willingness and ability of the patient to participate in all follow-up examinations.
Show all 27Show fewer
- Pregnancy (if suspicion of pregnancy s-hCG or u-hCG must be negative).
- Allergy or intolerance to any ingredients of IMP or placebo or gentamicin.
- Other conditions / circumstances likely to lead to poor treatment adherence (eg, history of poor compliance, alcohol or drug dependency, no fixed abode).
- Significant bleeding disorder either at present or within the past 6 months.
- Effective oral anticoagulant treatment, eg, warfarin sodium (INR >1.3).
- Effective anticoagulant treatment with heparin or low molecular weight heparin the last 48 hours.
- Any history of central nervous system damage (ie, neoplasm, aneurysm, intracranial or spinal surgery).
- Known hemorrhagic diathesis.
- Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with acute myocardial infarction).
- Recent non-compressible vessel puncture within 2 weeks.
- Recent trauma to the head or cranium.
- Prolonged cardiopulmonary resuscitation (>2 minutes) within the past 2 weeks.
- Acute pericarditis and/or subacute bacterial endocarditis.
- Acute pancreatitis.
- Severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (oesophageal varices) and active hepatitis.
- Active peptic ulceration.
- Arterial aneurysm and known arterial/venous malformation.
- Neoplasm with increased bleeding risk.
- Any known history of hemorrhagic stroke or stroke of unknown origin.
- Known history of ischemic stroke or transient ischemic attack in the preceding 3 months.
- Dementia.
Trial locations and contacts
18 sites in 6 countries.
18 sites in 6 countries
Norway8 sites
Haukeland University Hospital
Bergen
Vestre Viken Hospital Trust Drammen
Drammen
Østfold Hospital Trust Kalnes, Dept of Ophthalmology
Grålum
Helse Nord Trøndelag Trust
Namsos
Oslo University Hospital
Oslo, 0424
Telemark Hospital Trust
Skien
Vestfold Hospital Trust
Tønsberg
St Olav University Hospital
Trondheim
Denmark3 sites
Aarhus University Hospital
Aarhus
Bispebjerg University Hospital
Copenhagen
Rigshospitalet University Hospital
Copenhagen
Belgium2 sites
University Hospital Antwerp
Antwerp
University Hospital Leuven
Leuven, 3000
Finland2 sites
Helsinki University Hospital
Helsinki
Turku University Hospital
Turku
Lithuania2 sites
Kauno Klinikos Kaunas
Kaunas
Vilnius University Hospital
Vilnius
About this study
Official title: TENecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): A Randomized Placebo-controlled Trial of Early Systemic Tenecteplase Treatment in Patients With Central Retinal Artery Occlusion.
TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization).
A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days
Read the detailed description
Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt revascularization, bears high risk of permanent blindness. The condition is typically the result of an artery-to-artery embolism from a carotid plaque or cardio embolism. A recent meta-analysis of observational data indicates that prompt revascularization with systemic thrombolysis might improve outcome. A randomized controlled trial of early systemic thrombolysis for CRAO is therefore warranted. The aim of this project is to assess the effect of systemic tissue plasminogen activator tenecteplase versus placebo administered within 4.5 hours of CRAO onset in patients admitted to the participating hospitals in Europe. The main endpoint is the proportion of patients with ≤ 0.7 logMAR visual acuity 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR, equal to at least 15 letters/three lines on a visual acuity chart. In addition, we will access differences in visual field parameters and patient reported outcome measures between the groups. This study is based on a broad collaboration and interaction between leading ophthalmologists and neurologists in European centres.
- Conditions
- Central Retinal Artery Occlusion
- Being tested
- Intravenous injection of Tenecteplase and one dose of placebo tablet, One tablet of Acetylsalicylic Acid and one dose of IV placebo
- Keywords
- thrombolysis tenecteplase
- 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.
Intravenous injection of Tenecteplase and one dose of placebo tabletDrug
Also called Metalyse
Drug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg)
One tablet of Acetylsalicylic Acid and one dose of IV placeboDrug
Also called Aspirin
300 mg Acetylsalisylic acid
| Study group | Role | What they receive |
|---|---|---|
| Tenecteplase | Active comparator | The total dose of tenecteplase is 0.25 mg/kg body weight, maximum 25 mg. The total dose will be given as an intravenous bolus Receives: Drug: Intravenous injection of Tenecteplase and one dose of placebo tablet |
| acetylsalicylic acid | Active comparator | one tablet of aspirin 300 mg Other Name: Aspirin Receives: Drug: One tablet of Acetylsalicylic Acid and one dose of IV placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with ≤ 0.7 logMAR visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
logMAR
Measured: 30 (±5) days
Secondary outcomes (10)
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.
logMAR
Measured: 30 (±5) and 90 (±15) days
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days.
logMAR
Measured: 30 (±5) and 90 (±15) days
Proportion of patients with visual recovery (logMAR ≤ 0.7) and (logMAR ≤ 0.5) in the affected eye 30 (±5) and 90 (±15) days in patients who were treated with tenecteplase within 3 hours of onset
logMAR
Measured: 30 (±5) and 90 (±15) days
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days
Number of test points
Measured: 30 (±5) and 90 (±15) days
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs.
DWI lesions
Measured: 24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
NIHSS score
Measured: 24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
mRS score
Measured: Discharge, 30 (±5) and 90 days (±15) days.
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days
Visual function related quality of life at 30 and 90 days. Measures the dimensions of self-reported vision-targeted health status that are most important for persons who have chronic eye diseases. 100 = best possible, 0 = worst possible
Measured: 30 (±5) and 90 (±15) days
Mean score on EQ-5D at 30 (±5) and 90 (±15) days
Quality of life reported at 30 and 90 days. Health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Measured: 30 (±5) and 90 (±15) days
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
presence
Measured: 30 (±5) and 90 (±15) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2020
- Study start30 Oct 2020
- Primary completion20 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Oslo University HospitalThe 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
- Model description
- A prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Hege Aamodt, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04526951
- Sponsor's protocol ID
- Oslo UH
- Other IDs
- 2018-002546-36, 2019/327, 2024-517606-29-00, 2018
- Acronym
- TenCRAOS
- Status last verified
- Jun 2025
- First submitted
- 20 Aug 2020
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to share data with the THEIA trial and REVISION trial for IPD meta analysis
Publications
Ryan SJ, Jorstad OK, Skjelland M, Pesonen M, Simonsen CZ, Bek T, Blauenfeldt RA, Ijas P, Laitinen A, Khanevski A, Krohn J, Rodahl E, Lemmens R, Demeestere J, Cassiman C, Nakstad I, Evensen K, Sandell T, Hamann S, Truelsen TC, Christensen LM, Rosenbaum S, Matijosaitis V, Zemaitiene R, Ellekjaer H, Almaas E, Austeng D, Mazya MV, Traisk F, Ylikotila P, Salmi U, Jenssen KN, Lisether H, Breivik C, Devik K, Honningsvag LE, Valaikiene J, Cimbalas A, Malmberg VN, Anderson E, Roy A, Skattor TH, Kraglund KL, Kefaloykos C, Olsen IC, Vanacker P, Strbian D, Moe MC, Aamodt AH; TenCRAOS Investigators. A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion. N Engl J Med. 2026 Jan 29;394(5):442-450. doi: 10.1056/NEJMoa2508515.
PubMed 41604638
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TENecteplase in Central Retinal Artery Occlusion Study (TenCRAOS): A Randomized Placebo-controlled Trial of Early Systemic Tenecteplase Treatment in Patients With Central Retinal Artery Occlusion.
- ClinicalTrials.gov ID
- NCT04526951
- Acronym / sponsor ID
- TenCRAOS / Oslo UH
- Conditions
- Central Retinal Artery Occlusion
- Keywords
- thrombolysis tenecteplase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 26 Aug 2020 (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.
TENecteplase in Central Retinal Artery Occlusion (TenCRAOS): A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization).
A Prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomization). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days
Detailed description
Central retinal artery occlusion (CRAO) is an ophthalmologic emergency that, without prompt revascularization, bears high risk of permanent blindness. The condition is typically the result of an artery-to-artery embolism from a carotid plaque or cardio embolism. A recent meta-analysis of observational data indicates that prompt revascularization with systemic thrombolysis might improve outcome. A randomized controlled trial of early systemic thrombolysis for CRAO is therefore warranted. The aim of this project is to assess the effect of systemic tissue plasminogen activator tenecteplase versus placebo administered within 4.5 hours of CRAO onset in patients admitted to the participating hospitals in Europe. The main endpoint is the proportion of patients with ≤ 0.7 logMAR visual acuity 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR, equal to at least 15 letters/three lines on a visual acuity chart. In addition, we will access differences in visual field parameters and patient reported outcome measures between the groups. This study is based on a broad collaboration and interaction between leading ophthalmologists and neurologists in European centres.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A prospective, randomized-controlled, double-dummy, double-blind phase 3 multi-centre trial of TNK 0.25 mg/kg + placebo vs. ASA + placebo (2 arms with 1:1 block randomisation). At all participating centers, ophthalmologists are involved in the diagnosis and visual outcome measurements using a standardized protocol. The patients will be promptly examined by the ophthalmologist. As soon as the CRAO is diagnosed by the ophthalmologist, the patients will be managed in the stroke unit during treatment, monitoring, and medical investigations. After treatment in the stroke unit, the patients will be re-examined by an ophthalmologist and a neurologist as an out-patient at (30 ±5) and 90 (±15) days.
| Arm | Type | Receives |
|---|---|---|
| Tenecteplase | Active comparator | Drug: Intravenous injection of Tenecteplase and one dose of placebo tabletThe total dose of tenecteplase is 0.25 mg/kg body weight, maximum 25 mg. The total dose will be given as an intravenous bolus |
| acetylsalicylic acid | Active comparator | Drug: One tablet of Acetylsalicylic Acid and one dose of IV placeboone tablet of aspirin 300 mg Other Name: Aspirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-arteritic central retinal artery occlusion with ≥ 1.0 logMAR visual acuitiy and symptoms lasting less than 4.5 hours.
- Ability to administer the Investigator Medicinal Product (IMP) within 4.5 hours of symptom onset.
- Age ≥18 years.
- Informed written consent of the patient.
- A woman of childbearing potential (WOCBP) must confirm that in her opinion, she cannot be pregnant, OR if there is a possibility that she is pregnant, a negative pregnancy test must be confirmed before any IMP is given.
Key exclusion criteria (27 listed)
- Other active intervention targeting CRAO.
- Branch retinal artery occlusion, cilioretinal artery supplying the macula, combined arterial-venous occlusion, proliferative diabetic retinopathy, elevated intraocular pressure (> 30 mmHg) or clinical suspicion of ophthalmic artery occlusion occlusion (e.g. choroidal nonperfusion, absence of cherry red spot, no light perception).
- Systemic diseases; severe general diseases, systemic arterial hypertension (blood pressure >185/110 mmHg), despite medical therapy, or clinical suspicion of acute systemic inflammation.
- Presence of intracranial haemorrhage on brain MRI/CT.
- Medical history: heart attack within the last 6 weeks, intracerebral bleeding or neurosurgical operation within the last 4 weeks, therapy with anticoagulation, allergic reaction to contrast agent, hemorrhagic diathesis, aneurysms, inflammatory vascular diseases (eg, giant cell arteritis, granulomatosis with polyangitis), endocarditis, or gastric ulcer.
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 |
|---|---|---|
| Intravenous injection of Tenecteplase and one dose of placebo tabletAlso: MetalyseDrug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg) | Drug | Tenecteplase |
| One tablet of Acetylsalicylic Acid and one dose of IV placeboAlso: Aspirin300 mg Acetylsalisylic acid | Drug | acetylsalicylic acid |
Primary outcome
Proportion of patients with ≤ 0.7 logMAR visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis).
Time frame: 30 (±5) days
logMAR
10 secondary outcomes
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.
Time frame: 30 (±5) and 90 (±15) days
Mean improvement in logMAR visual acuity in the affected eye from baseline to 30 (±5) and 90 (±15) days.
Time frame: 30 (±5) and 90 (±15) days
Proportion of patients with visual recovery (logMAR ≤ 0.7) and (logMAR ≤ 0.5) in the affected eye 30 (±5) and 90 (±15) days in patients who were treated with tenecteplase within 3 hours of onset
Time frame: 30 (±5) and 90 (±15) days
Number of test points seen (of 100) on monocular Esterman perimetry at 30 (±5) and 90 (±15) days
Time frame: 30 (±5) and 90 (±15) days
Acute ischemic lesions on follow-up on diffusion-weighted (DWI) MRI or on brain CT at baseline and 24hrs.
Time frame: 24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
Time frame: 24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
Time frame: Discharge, 30 (±5) and 90 days (±15) days.
Mean score on National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) at 30 (±5) and 90 (±15) days
Time frame: 30 (±5) and 90 (±15) days
Mean score on EQ-5D at 30 (±5) and 90 (±15) days
Time frame: 30 (±5) and 90 (±15) days
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
Time frame: 30 (±5) and 90 (±15) days
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 29 Sep 2025.
- Derived from this study: PubMed 41604638Ryan SJ, Jorstad OK, Skjelland M, Pesonen M, Simonsen CZ, Bek T, Blauenfeldt RA, Ijas P, Laitinen A, Khanevski A, Krohn J, Rodahl E, Lemmens R, Demeestere J, Cassiman C, Nakstad I, Evensen K, Sandell T, Hamann S, Truelsen TC, Christensen LM, Rosenbaum S, Matijosaitis V, Zemaitiene R, Ellekjaer H, Almaas E, Austeng D, Mazya MV, Traisk F, Ylikotila P, Salmi U, Jenssen KN, Lisether H, Breivik C, Devik K, Honningsvag LE, Valaikiene J, Cimbalas A, Malmberg VN, Anderson E, Roy A, Skattor TH, Kraglund KL, Kefaloykos C, Olsen IC, Vanacker P, Strbian D, Moe MC, Aamodt AH; TenCRAOS Investigators. A Randomized Trial of Tenecteplase in Acute Central Retinal Artery Occlusion. N Engl J Med. 2026 Jan 29;394(5):442-450. doi: 10.1056/NEJMoa2508515.
- Individual participant dataSharing planned: Yes. There is a plan to share data with the THEIA trial and REVISION trial for IPD meta analysis
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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.
18 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Central Retinal Artery Occlusion, run by Oslo University Hospital at 18 sites in 6 countries.
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 27 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 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Norway, Denmark, Belgium, Finland, Lithuania and 1 more country. 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?
Proportion of patients with ≤ 0.7 logMAR visual acuity in the affected eye at 30 (±5) days after treatment, representing an improvement in visual acuity of at least 0.3 logMAR (intention-to-treat (ITT) analysis). (time frame: 30 (±5) 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 NCT04526951, which also lists 1 linked publication.
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 29 Sep 2025.