Surgical Stabilizer Assisted RVC With rtPA for CRVO

• Status: Completed
• Trial end date: 2017-05-04
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Treatments: Tissue Plasminogen Activator

Criteria

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 (NVD/NVE/NVI/NVA)

• 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