Status:
WITHDRAWN
Surgical Stabilizer Assisted RVC With rtPA for CRVO
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Conditions:
Central Retinal Vein Occlusion
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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...
Detailed 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 patient...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 10 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03417401
Start Date
October 16 2018
End Date
December 10 2021
Last Update
March 23 2023
Active Locations (1)
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1
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000