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Surgical Stabilizer Assisted RVC With rtPA for CRVO | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

Surgical Stabilizer Assisted RVC With rtPA for CRVO

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).

NCT03417401•Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - No limit years

Sex

ALL

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

Locations (1)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Key Dates

Start Date

October 16, 2018

Primary Completion Date

December 10, 2021

Completion Date

December 10, 2021

Last Updated

March 23, 2023

Conditions

Central Retinal Vein Occlusion

Interventions

Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.

PROCEDURE

Intravenous Infusion

DRUG

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 23, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Surgical Stabilizer Assisted RVC With rtPA for CRVO

Inclusion Criteria

Exclusion Criteria

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