Surgical Stabilizer Assisted RVC With rtPA for CRVO

March 22, 2023 updated by: Universitaire Ziekenhuizen KU Leuven

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).

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 ( 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).
Other Names:
  • Recombinant tissue Plasminogen Activator (rtPA)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Success rate of retinal vein cannulation
Time Frame: 10 min
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.
10 min
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)
7 days
duration of infusion
Time Frame: 10 minutes
The time of infusion measured during surgery with a maximum of 10 minutes
10 minutes
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 CT-scan/ultrasound after referral to vascular surgeon)
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in visual acuity after 6 to 8 weeks
Time Frame: 6-8 weeks
best corrected visual acuity tested with ETDRS chart
6-8 weeks
change in central macular thickness after 6 to 8 weeks
Time Frame: 6-8 weeks
measurement of central macular thickness with spectral domain-OCT
6-8 weeks
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
7 days
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/intraocular lens (IOL). Recombinant tissue Plasminogen Activator (rtPA) as seen through the surgical microscope (occurred/not occurred)
7 days
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)
7 days
change in retinal flow intraoperatively visualized with OCT-angiography
Time Frame: 1 hour
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.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universitaire Ziekenhuizen KU Leuven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Peter Stalmans, UZ Leuven

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 16, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 10, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 31, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • S61283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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