Clincosm LogoSign in Get a demo

THEIA: 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

Sponsor
Nantes University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03197194
Collaborator
(none)
70
Enrollment
24
Locations
2
Arms
75.8
Anticipated Duration (Months)
2.9
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: Alteplase
  • Drug: acetylsalicylic acid
  • Drug: Placebo Oral Tablet
  • Drug: placebo IV
 Phase 3

Study Design

Study Type:
Interventional
Anticipated 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 :
Jun 8, 2018
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

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 Names:
  • Actilyse

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Tolerance [3 months]

      Number, type and grade of severity of adverse drug reactions

    2. 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.

    3. Visual field [3 months]

      Visual field at 3 months.

    4. Time course of VA on ETDRS chart or ordinal scale [3 months]

    5. Time-to-treatment administration impact on VA evolution. [1 month]

      Mean VA improvement according to the time between onset of sign and treatment administration

    6. Global disability (modified Rankin scale) after treatment [3 months]

    7. Quality of life related to vision (NEI-VFQ-25) after treatment [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU d'Angers Angers France 49933
    2 CH Annecy Genevois Annecy France
    3 CH d'Arras Arras France 62022
    4 CHRU de Besançon Besançon France 25030
    5 CHU de Bordeaux Bordeaux France 33000
    6 CHU Caen Caen France
    7 CH métropole Savoie Chambéry France 73000
    8 CHD Vendée La Roche-sur-Yon France 85000
    9 CH de La Rochelle La Rochelle France 17019
    10 CHU Lyon France
    11 CHU de Montpellier Montpellier France 34295
    12 CHU de Nantes Nantes France 44093
    13 CHU de Nice Nice France 06001
    14 Fondation Ophtalmologique Rothschild Paris France 75019
    15 Ch Perpignan Perpignan France
    16 CHU de Poitiers Poitiers France 86021
    17 CHU de Rennes Rennes France 35033
    18 CHU Rouen Rouen France
    19 CH de Saint Nazaire Saint-Nazaire France 44606
    20 CHU de Strasbourg Strasbourg France 67200
    21 CHU de Toulouse Toulouse France 31059
    22 CHU de Tours Tours France 37044
    23 CH Vannes Vannes France
    24 Vienne Hospital Vienne France

    Sponsors and Collaborators

    • Nantes University Hospital

    Investigators

    • Principal Investigator: Benoit GUILLON, Dr, CHU de Nantes

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nantes University Hospital
    ClinicalTrials.gov Identifier:
    NCT03197194
    Other Study ID Numbers:
    • RC17_0061
    First Posted:
    Jun 23, 2017
    Last Update Posted:
    Apr 27, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    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:
    Retinal Artery Occlusion
    Arterial Occlusive Diseases
    Aspirin
    Tissue Plasminogen Activator

    Study Results

    No Results Posted as of Apr 27, 2022