Surgical Stabilizer Assisted RVC With rtPA for CRVO

NCT ID: NCT03417401

Last Updated: 2023-03-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-16
• Study Completion Date: 2021-12-10

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).

Conditions

Central Retinal Vein Occlusion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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..

Intravenous Infusion

Intervention Type: DRUG

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

Interventions

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..

Intervention Type: PROCEDURE

Intravenous Infusion

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

Intervention Type: DRUG

Other Intervention Names

Recombinant tissue Plasminogen Activator (rtPA)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Stalmans

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

Universitaire Ziekenhuizen Leuven

Leuven, , Belgium

Countries

Belgium

Other Identifiers

S61283

Identifier Type: -

Identifier Source: org_study_id