Central Retinal Artery Occlusion
Conditions
Keywords
Central retinal artery occlusion, visual acuity, visual field, mRs, NEI-VFQ-25
Brief summary
The aim of the THEIA study is to determine if Alteplase administrated within 4.5 hours improve visual deficit due to acute CRAO with a good safety profile.
Interventions
DRUGAlteplase
alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour.
DRUGacetylsalicylic acid
one tablet of aspirin 300 mg
DRUGPlacebo Oral Tablet
One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
DRUGplacebo IV
IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged up to 18 years * CRAO diagnosis by fundoscopic examination or non-mydriatic retinophotography (NMR) performed by an ophthalmologist. * Blindness defined according to WHO classification as visual acuity \<1/20 (20/400). * Treatment intervention should be initiated by a stroke team as quickly as possible and within 4.5 hours from symptom onset. * No clinical (e.g headache with jaw claudication or scalp tenderness, no temporal pulse) or laboratory evidence (elevated CRP) of giant cell arteritis * No clinical or radiological evidence of stroke within the last 3 months. * Patients covered by health care insurance (social security) * Written informed consent obtained.
Exclusion criteria
* Symptoms onset more than 4.5 h prior to infusion start or undetermined time of symptom onset. * Minor VA deficit or VA rapidly improving before start of infusion. * CRAO without foveal ischemia. * Other retinal vascular disease: occlusion of branch of the CRA without significant VA loss, occlusion of the retinal vein, proliferative diabetic retinopathy or any other severe retinopathy. * Clinical or laboratory evidence of temporal arteritis. * Evidence of ICH or ischemic stroke on the pre-administration CT scan or MRI. * Pregnant or lactating women * Minors * Adults under guardianship or trusteeship * Any contraindication to alteplase * Any contraindication to aspirin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| visual acuity (VA) improvement after treatment | 1 month | Improvement of the VA is defined by a gain of 15 letters or more on the ETDRS VA chart or ordinal scale |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of blindness patients after treatment | 1 month | Blindness is defined according to WHO revised categories of visual impairment, as VA \< 1/20 (\< 20/400 or \> 1.3 log.MAR) or visual field \< 10. |
| Visual field | 3 months | Visual field at 3 months. |
| Time course of VA on ETDRS chart or ordinal scale | 3 months | — |
| Tolerance | 3 months | Number, type and grade of severity of adverse drug reactions |
| Global disability (modified Rankin scale) after treatment | 3 months | — |
| Quality of life related to vision (NEI-VFQ-25) after treatment | 3 months | — |
| Time-to-treatment administration impact on VA evolution. | 1 month | Mean VA improvement according to the time between onset of sign and treatment administration |
Countries
France
Outcome results
None listed