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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
81
Drug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg)
300 mg Acetylsalisylic acid
University Hospital Antwerp
Antwerp, Belgium
University Hospital Leuven
Leuven, Belgium
Aarhus University Hospital
Aarhus, Denmark
Bispebjerg University Hospital
Copenhagen, Denmark
Rigshospitalet University Hospital
Copenhagen, Denmark
Helsinki University Hospital
Helsinki, Finland
Turku University Hospital
Turku, Finland
Kauno Klinikos Kaunas
Kaunas, Lithuania
Vilnius University Hospital
Vilnius, Lithuania
Haukeland University Hospital
Bergen, Norway
...and 8 more locations
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
Time frame: 30 (±5) days
Proportion of patients with ≤ 0.5 logMAR visual acuity in the affected eye at 30 (±5) and 90 (±15) days.
logMAR
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.
logMAR
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
logMAR
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
Number of test points
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.
DWI lesions
Time frame: 24 hours
National Institutes of Health Stroke Scale score (NIHSS) at 24hrs and discharge.
NIHSS score
Time frame: 24 hours
Modified Rankin Scale score (mRS) at discharge, 30 (±5) and 90 days (±15) days.
mRS score
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
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
Time frame: 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.
Time frame: 30 (±5) and 90 (±15) days
Presence of ocular neovascularisation at 30 (±5) and 90 (±15) days
presence
Time frame: 30 (±5) and 90 (±15) days
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