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Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03417401
Study type Interventional
Source Universitaire Ziekenhuizen KU Leuven
Contact
Status Withdrawn
Phase Phase 1
Start date October 16, 2018
Completion date December 10, 2021

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