Surgical Stabilizer Assisted RVC With rtPA for CRVO

Phase 1

Withdrawn

• Conditions: Central Retinal Vein Occlusion
• Interventions: Procedure: Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.; Drug: Intravenous Infusion

• Registration Number: NCT03417401
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 dedicated surgical stabiliser for the treatment of central retinal vein occlusion.

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 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).

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2018-01-24
• Study First Posted: 2018-01-31
• Study Start: 2018-10-16
• Primary Completion: 2021-12-10
• Study Completion: 2021-12-10
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-22
• Last Update Posted: 2023-03-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RVC with tPA for CRVO	Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.	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.
RVC with tPA for CRVO	Intravenous Infusion	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.

Primary Outcome Measures

Name	Time	Method
duration of infusion	10 minutes	The time of infusion measured during surgery with a maximum of 10 minutes
Success rate of retinal vein cannulation	10 min	successful cannulation defined as peroperatively seen washout of blood in the cannulated retinal vein. The success rate is defined as the number of successful cannulations divided by the total number of cannulation attempts.
number of intervention-related non-surgical complications	7 days	The postoperative occurence of: * hemorrhagic cerebrovascular accidents due to rtPA (confirmed by CT-scan and neurological examination after referral to the neurologist); * large hemorrhage elsewhere to be related with the use of rtPA (as confirmed by clinical examination and/or CT-scan/ultrasound after referral to vascular surgeon)
number of intervention-related surgical complications	7 days	These exist of the intra-operative occurence of: * retinal vein tear (visually seen by the surgeon); * uncontrollable vitreous cavity hemorrhage (as seen by the surgeon); * retinal tear in the proximity of the cannulation site (as seen by the surgeon); * intra-/subretinal injection (as seen by the surgeon); * breakage of the needle (as seen by the surgeon); * failure of stabilizer in holding the instrument immobilized in a certain position (as seen by the surgeon)

Secondary Outcome Measures

Name	Time	Method
intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA	7 days	- complications during vitrectomy: * retinal tears as seen through the surgical microscope (occurred/not occurred); * vitreous hemorrhage as seen through the surgical microscope (occurred/not occurred); * choroidal swelling as seen through the surgical microscope (present/absent); * suprachoroidal hemorrhage as seen through the surgical microscope (present/absent)
change in visual acuity after 6 to 8 weeks	6-8 weeks	best corrected visual acuity tested with ETDRS chart
change in retinal flow intraoperatively visualized with OCT-angiography	1 hour	OCT-angiography visualized flow inside the retinal veins with the intraoperative OCT device; if there is flow the blood vessel is imaged in bright white, if there is no flow the blood vessel is not visible with angio-OCT.
change in central macular thickness after 6 to 8 weeks	6-8 weeks	measurement of central macular thickness with spectral domain-OCT

Trial Locations

Locations (1)

Universitaire Ziekenhuizen Leuven; 🇧🇪 Leuven, Belgium