Phase I RVC With Ocriplasmin for CRVO

• Status: Completed
• Trial end date: 2017-08-11
• Target enrollment: 0
• Participant gender: All

Summary

In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the entire retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema and neovascularization. The development of a microneedle and surgical stabilizer made it possible to perform a prolonged (10 minutes) retinal vein cannulation with infusion of Ocriplasmin. Ocriplasmin has the advantage over tissue Plasminogen Activator (tPA) that it already is an active enzyme and a strong fibrinolyticum. This study aims to investigate the feasibility and safety of local intravenous Ocriplasmin for CRVO.

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

Details

• Lead Sponsor: Universitaire Ziekenhuizen Leuven
• Collaborators: Katholieke Universiteit Leuven; KU Leuven
• Treatments: Fibrinolysin

Criteria

Inclusion Criteria:

• Patients aged over 18 years

• Recent diagnosis of CRVO

• Onset of symptoms <10 days

• Visual acuity < 2/10 in study eye

• Visual acuity >1/10 in fellow eye

• Central macular thickness >250µm and <1000 µm

• Signed informed consent prior to inclusion

Exclusion Criteria:

• Fluorescein allergy

• Active neovascularization (NVD/NVE/NVI/NVA)

• Eye disease other than CRVO or Cataract decreasing vision

• Use of acetazolamide or other drugs potentially affecting macular edema, including systemic steroids >10mg/d

• History of retinal surgery

• High myopia (> -10D)

• Contraindication for the use of systemic anticoagulant medication