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Trial record 29 of 81 for:    CRVO - Central Retinal Vein Occlusion

Surgical Stabilizer Assisted RVC With rtPA for CRVO

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ClinicalTrials.gov Identifier: NCT03417401
Recruitment Status : Not yet recruiting
First Posted : January 31, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:
This phase Ib study investigates the safety and efficacy of performing a retinal vein cannulation with recombinant tissue Plasminogen Activator infusion into a retinal vein with the help of an updated dedicated surgical stabiliser for the treatment of central retinal vein occlusion.

Condition or disease Intervention/treatment Phase
Central Retinal Vein Occlusion Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg. Drug: Intravenous Infusion Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation With tPA Infusion Confirmed by Intraoperative Angio-OCT for the Treatment of CRVO
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Alteplase

Arm Intervention/treatment
Experimental: RVC with tPA for CRVO
Single arm phase I open label study were CRVO patients will have a vitrectomy with retinal vein cannulation and a single infusion of tPA (0.25mg/ml) intravenously with a maximum dose of 1mg.
Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.
Standard 3-port pars plana vitrectomy with surgical stabilizer assisted (mynutia surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg..

Drug: Intravenous Infusion
Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).




Primary Outcome Measures :
  1. Success rate of retinal vein cannulation [ Time Frame: 10 min ]
    successful cannulation defined as peroperatively seen washout of blood in the cannulated retianl vein. The success rate is defined as the number of succesful cannulations divided by the total number of cannulation attempts.

  2. number of intervention-related surgical complications [ Time Frame: 7 days ]

    These exist of the intra-operative occurence of:

    • retinal vein tear (visually seen by the surgeon)
    • uncontrollable vitreous cavity hemorrhage (as seen by the surgeon)
    • retinal tear in the proximity of the cannulation site (as seen by the surgeon)
    • intra-/subretinal injection (as seen by the surgeon)
    • breakage of the needle (as seen by the surgeon)
    • failure of stabilizer in holding the instrument immobilized in a certain position (as seen by the surgeon)

  3. duration of infusion [ Time Frame: 10 minutes ]
    The time of infusion measured during surgery with a maximum of 10 minutes

  4. number of intervention-related non-surgical complications [ Time Frame: 7 days ]

    The postoperative occurence of:

    • hemorrhagic cerebrovascular accidents due to rtPA (confirmed by CT-scan and neurological examination after referral to the neurologist)
    • large hemorrhage elsewhere to be related with the use of rtPA (as confirmed by clinical examination and/or CTscan/ultrasound after referral to vascular surgeon)


Secondary Outcome Measures :
  1. change in visual acuity after 6 to 8 weeks [ Time Frame: 6-8 weeks ]
    best corrected visual acuity tested with ETDRS chart

  2. change in central macular thickness after 6 to 8 weeks [ Time Frame: 6-8 weeks ]
    measurement of central macular thickness with spectral domain-OCT

  3. intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA [ Time Frame: 7 days ]

    - complications of intraocular surgery:

    • wound leak tested with concentrated fluorescein (Seidel effect present/absent)
    • endophthalmitis as seen with the slit lamp/ultrasonography
    • post-operative macular edema objectivated with OCT imaging
    • vitreous hemorrhage > 2 weeks after intervention as seen at the slit lamp and confirmed with ultrasonography
    • development of neovascularization as seen at the slit lamp / fluorescein angiogram

  4. intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA [ Time Frame: 7 days ]

    - complications during cataract surgery:

    • iris hemorrhage as seen through the surgical microscope (present/absent)
    • choroidal swelling as seen through the surgical microscope (present/absent)
    • suprachoroidal hemorrhage as seen through the surgical microscope (present/absent)
    • capsule tear as seen through the surgical microscope (present/absent)
    • dropped lens/IOL as seen through the surgical microscope (occurred/not occurred)

  5. intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA [ Time Frame: 7 days ]

    - complications during vitrectomy:

    • retinal tears as seen through the surgical microscope (occurred/not occurred)
    • vitreous hemorrhage as seen through the surgical microscope (occurred/not occurred)
    • choroidal swelling as seen through the surgical microscope (present/absent)
    • suprachoroidal hemorrhage as seen through the surgical microscope (present/absent)

  6. change in retinal flow intraoperatively visualized with OCT-angiography [ Time Frame: 1 hour ]
    OCT-angiography visualzed flow inside the retinal veins with the intraoperative OCT device; if there is flow the blood vessel is imaged in bright white, if there is no flow the blood vessel is not visible with angio-OCT.



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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 over 18 years
  • Recent diagnosis (<8 weeks) of CRVO
  • Recent onset of symptoms (<12 weeks)
  • Visual acuity < 5/10 in study eye
  • Visual acuity >1/10 in fellow eye
  • Central macular thickness >250µm
  • Signed informed consent prior to inclusion

Exclusion Criteria:

  • Fluorescein allergy
  • Active neovascularization (NVD/NVE/NVI/NVA)
  • Eye disease other than CRVO or Cataract decreasing central vision
  • History of retinal surgery
  • High myopia (> -10D)
  • Contraindication for the use of systemic anticoagulant medication
  • Extensive macular ischemia noted on fluo-angiography

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): NCT03417401


Locations
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Belgium
UZ Leuven
Leuven, Vlaams Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven

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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT03417401     History of Changes
Other Study ID Numbers: PhaseIbRVCforCRVO
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Retinal Vein Occlusion
Retinal Diseases
Venous Thrombosis
Eye Diseases
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Tissue Plasminogen Activator
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action