Surgical Stabilizer Assisted RVC With rtPA for CRVO

Universitaire Ziekenhuizen KU Leuven

Status and phase: Withdrawn; Phase 1

Conditions: Central Retinal Vein Occlusion

Treatments: Drug: Intravenous Infusion; Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.

Study type: Interventional

Funder types: Other

Identifiers

NCT03417401

S61283

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

RVC with tPA for CRVO

Experimental group

Description:

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.

Treatment:

Drug: Intravenous Infusion

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