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A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion (THEIA)

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ClinicalTrials.gov Identifier: NCT03197194
Recruitment Status : Recruiting
First Posted : June 23, 2017
Last Update Posted : February 19, 2020
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Central Retinal Artery Occlusion Drug: Alteplase Drug: acetylsalicylic acid Drug: Placebo Oral Tablet Drug: placebo IV Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Randomized, Blind, Double Dummy, Multicenter Study Assessing the Efficacy and Safety of IV THrombolysis (Alteplase) in Patients With acutE Central retInal Artery Occlusion
Actual Study Start Date : June 8, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: A : Alteplase
Intravenous injection of Alteplase and one tablet of placebo
Drug: Alteplase
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.
Other Name: Actilyse

Drug: Placebo Oral Tablet
One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
Other Name: Placebo aspirin

Active Comparator: B : Acetylsalicylic Acid
one tablet of Acetylsalicylic Acid and one dose of IV placebo
Drug: acetylsalicylic acid
one tablet of aspirin 300 mg
Other Name: Aspirin

Drug: placebo 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
Other Name: Placebo Actilyse




Primary Outcome Measures :
  1. visual acuity (VA) improvement after treatment [ Time Frame: 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 Outcome Measures :
  1. Tolerance [ Time Frame: 3 months ]
    Number, type and grade of severity of adverse drug reactions

  2. Proportion of blindness patients after treatment [ Time Frame: 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.

  3. Visual field [ Time Frame: 3 months ]
    Visual field at 3 months.

  4. Time course of VA on ETDRS chart or ordinal scale [ Time Frame: 3 months ]
  5. Time-to-treatment administration impact on VA evolution. [ Time Frame: 1 month ]
    Mean VA improvement according to the time between onset of sign and treatment administration

  6. Global disability (modified Rankin scale) after treatment [ Time Frame: 3 months ]
  7. Quality of life related to vision (NEI-VFQ-25) after treatment [ Time Frame: 3 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03197194


Contacts
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Contact: Benoit GUILLON, Dr +33(0) 2 40 16 51 99 benoit.guillon@chu-nantes.fr
Contact: Cécile PRETERRE, Dr cecile.preterre@chu-nantes.fr

Locations
Show Show 18 study locations
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Benoit GUILLON, Dr CHU de Nantes

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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03197194    
Other Study ID Numbers: RC17_0061
First Posted: June 23, 2017    Key Record Dates
Last Update Posted: February 19, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Nantes University Hospital:
Central retinal artery occlusion
visual acuity
visual field
mRs
NEI-VFQ-25
Additional relevant MeSH terms:
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Retinal Artery Occlusion
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Retinal Diseases
Eye Diseases
Aspirin
Tissue Plasminogen Activator
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics