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Surgical Stabilizer Assisted RVC With rtPA for CRVO

Primary Purpose

Central Retinal Vein Occlusion

Status
Withdrawn
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.
Intravenous Infusion
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • 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

Sites / Locations

  • Universitaire Ziekenhuizen Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

RVC with tPA for CRVO

Arm Description

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.

Outcomes

Primary Outcome Measures

Success rate of retinal vein cannulation
successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
number of intervention-related surgical complications
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)
duration of infusion
The time of infusion measured during surgery with a maximum of 10 minutes
number of intervention-related non-surgical complications
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 CT-scan/ultrasound after referral to vascular surgeon)

Secondary Outcome Measures

change in visual acuity after 6 to 8 weeks
best corrected visual acuity tested with ETDRS chart
change in central macular thickness after 6 to 8 weeks
measurement of central macular thickness with spectral domain-OCT
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- 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
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- 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/intraocular lens (IOL). Recombinant tissue Plasminogen Activator (rtPA) as seen through the surgical microscope (occurred/not occurred)
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
- 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)
change in retinal flow intraoperatively visualized with OCT-angiography
OCT-angiography visualized 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.

Full Information

First Posted
November 20, 2017
Last Updated
March 22, 2023
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT03417401
Brief Title
Surgical Stabilizer Assisted RVC With rtPA for CRVO
Official Title
Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Withdrawn
Why Stopped
organizationally not yet possible
Study Start Date
October 16, 2018 (Anticipated)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
December 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
Detailed Description
Investigator-initiated, unmasked, single-arm, mono-center, prospective, interventional case series phase Ib trial. In line with the previous phase I trial, this trial will be biphasic; first 3 patients will be included, when the procedure and product prove to be safe and an added value is noted from the intra-operative OCT-angiography, another 3 will be included afterwards (≥21 days between last inclusion of the first group and first inclusion of the second group).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Retinal Vein Occlusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RVC with tPA for CRVO
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.
Intervention Description
Standard 3-port pars plana vitrectomy with surgical stabilizer assisted ( surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg..
Intervention Type
Drug
Intervention Name(s)
Intravenous Infusion
Other Intervention Name(s)
Recombinant tissue Plasminogen Activator (rtPA)
Intervention Description
Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).
Primary Outcome Measure Information:
Title
Success rate of retinal vein cannulation
Description
successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
Time Frame
10 min
Title
number of intervention-related surgical complications
Description
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)
Time Frame
7 days
Title
duration of infusion
Description
The time of infusion measured during surgery with a maximum of 10 minutes
Time Frame
10 minutes
Title
number of intervention-related non-surgical complications
Description
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 CT-scan/ultrasound after referral to vascular surgeon)
Time Frame
7 days
Secondary Outcome Measure Information:
Title
change in visual acuity after 6 to 8 weeks
Description
best corrected visual acuity tested with ETDRS chart
Time Frame
6-8 weeks
Title
change in central macular thickness after 6 to 8 weeks
Description
measurement of central macular thickness with spectral domain-OCT
Time Frame
6-8 weeks
Title
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Description
- 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
Time Frame
7 days
Title
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Description
- 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/intraocular lens (IOL). Recombinant tissue Plasminogen Activator (rtPA) as seen through the surgical microscope (occurred/not occurred)
Time Frame
7 days
Title
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
Description
- 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)
Time Frame
7 days
Title
change in retinal flow intraoperatively visualized with OCT-angiography
Description
OCT-angiography visualized 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.
Time Frame
1 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Stalmans
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaire Ziekenhuizen Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Surgical Stabilizer Assisted RVC With rtPA for CRVO

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