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Surgical Stabilizer Assisted RVC With rtPA for CRVO

NCT03417401 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-03-23

No results posted yet for this study

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.

Conditions

  • Central Retinal Vein Occlusion

Interventions

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).

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Peter Stalmans · UZ Leuven

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2021-12-10
Completion
2021-12-10

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03417401 on ClinicalTrials.gov