NCT03417401

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).

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2018-10-16
• Primary completion: 2021-12-10
• Completion: 2021-12-10
• First posted: 2018-01-31
• Last updated: 2023-03-23

Locations

1 site across 1 country: Belgium