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Surgical Stabilizer Assisted RVC With rtPA for CRVO

U

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Withdrawn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

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)

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.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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