Early Reperfusion Therapy for Recovery of Vision in Acute Central RetinalArtery Occlusio
- Conditions
- Acute non-arteritic central retinal artery occlusion (CRAO)MedDRA version: 20.0Level: LLTClassification code: 10007971Term: Central retinal artery occlusion Class: 10015919Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- CTIS2023-507388-21-00
- Lead Sponsor
- niversitaetsklinikum Tuebingen AöR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1422
Age = 18 years, 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)
Suspected giant cell arteritis, Other-than-CRAO cause of acute visual loss (e.g., retinal detachment, vitreous hemorrhage, acute glaucoma, acute optic neuritis), 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Functional recovery to best corrected visual acuity (BCVA) of Logarithm<br>of the Minimum Angle of Resolution (LogMAR) = 0.5 (normal to mild<br>vision impairment according to WHO ICD-11 (WHO, 2019)) in the<br>affected eye at Visit (V) 3 (30 ± 5 days), dichotomized ITT analysis<br>(functional recovery to LogMAR = 0.5 vs. no functional recovery, i.e.,<br>LogMAR > 0.5);Secondary Objective: To investigate efficacy of IVT using alternative endpoints as well as to investigate safety of IVT in non-arteritic CRAO.;Primary end point(s): Primary efficacy endpoint of the interventional study: Functional recovery to best corrected visual acuity (BCVA) of Logarithm of the Minimum Angle of Resolution (LogMAR) = 0.5 (normal to mild vision impairment according to WHO ICD-11) in the affected eye at Visit (V) 3 (30 ± 5 days), intention-to-treat (ITT) analysis
- Secondary Outcome Measures
Name Time Method