Central Retinal Vein Occlusion Clinical Trial
Official title:
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).
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.
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). ;
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