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Surgical Stabilizer Assisted RVC With rtPA for CRVO

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Completed
CT.gov ID
NCT03417401
Collaborator
(none)
4
Enrollment
1
Location
1
Arm
3.7
Actual Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.
  • Drug: Intravenous Infusion
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
4 participants
Allocation:
N/A
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
Actual Study Start Date :
Jan 11, 2017
Actual Primary Completion Date :
Apr 13, 2017
Actual Study Completion Date :
May 4, 2017

Arms and Interventions

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).

Outcome Measures

Primary Outcome Measures

  1. Success rate of retinal vein cannulation [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 [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 [10 minutes]

    The time of infusion measured during surgery with a maximum of 10 minutes

  4. number of intervention-related non-surgical complications [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 [6-8 weeks]

    best corrected visual acuity tested with ETDRS chart

  2. change in central macular thickness after 6 to 8 weeks [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 UZ Leuven Leuven Vlaams Brabant Belgium 3000

Sponsors and Collaborators

  • Universitaire Ziekenhuizen Leuven

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT03417401
Other Study ID Numbers:
  • PhaseIbRVCforCRVO
First Posted:
Jan 31, 2018
Last Update Posted:
May 7, 2020
Last Verified:
Nov 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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:
Retinal Vein Occlusion
Tissue Plasminogen Activator

Study Results

No Results Posted as of May 7, 2020