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Early Reperfusion Therapy for Recovery of Vision in Acute Central Retinal Artery Occlusion
EU CTIS ID: 2023-507388-21-00
What this study is testing
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 (WHO, 2019)) in the affected eye at Visit (V) 3 (30 ± 5 days), dichotomized ITT analysis (functional recovery to LogMAR ≤ 0.5 vs. no functional recovery, i.e., LogMAR > 0.5)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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)
You likely can't join if
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.