Clinical trial NCT03417401: Surgical Stabilizer Assisted RVC With rtPA for CRVO
Official title: Phase Ib Study on Surgical Stabilizer Assisted Retinal Vein Cannulation (RVC) With tPA Infusion Confirmed by Intraoperative Angio-optical Coherence Tomography (Angio-OCT) for the Treatment of Central Retinal Vein Occlusion (CRVO).
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Central Retinal Vein Occlusion
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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
* 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

Primary outcomes:
measure: Success rate of retinal vein cannulation
timeFrame: 10 min
measure: number of intervention-related surgical complications
timeFrame: 7 days
measure: duration of infusion
timeFrame: 10 minutes
measure: number of intervention-related non-surgical complications
timeFrame: 7 days
Secondary outcomes:
measure: change in visual acuity after 6 to 8 weeks
timeFrame: 6-8 weeks
measure: change in central macular thickness after 6 to 8 weeks
timeFrame: 6-8 weeks
measure: intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
timeFrame: 7 days
measure: intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
timeFrame: 7 days
measure: intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA
timeFrame: 7 days
measure: change in retinal flow intraoperatively visualized with OCT-angiography
timeFrame: 1 hour
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuizen Leuven
Study officials:
affiliation: UZ Leuven
name: Peter Stalmans
role: PRINCIPAL_INVESTIGATOR
References: