Surgical Stabilizer Assisted RVC With rtPA for CRVO

Universitaire Ziekenhuizen KU Leuven

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Conditions

Central Retinal Vein Occlusion

Interventions

Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.PROCEDURE

Standard 3-port pars plana vitrectomy with surgical stabilizer assisted ( surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg..

Intravenous InfusionDRUG

Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Universitaire Ziekenhuizen Leuven

Leuven, Belgium

Outcomes

Primary Outcomes

Success rate of retinal vein cannulation

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.

Time frame: 10 min

number of intervention-related surgical complications

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)

Time frame: 7 days

duration of infusion

The time of infusion measured during surgery with a maximum of 10 minutes

Time frame: 10 minutes

number of intervention-related non-surgical complications

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)

Time frame: 7 days

Secondary Outcomes

change in visual acuity after 6 to 8 weeks

best corrected visual acuity tested with ETDRS chart

Time frame: 6-8 weeks

change in central macular thickness after 6 to 8 weeks

measurement of central macular thickness with spectral domain-OCT

Data from ClinicalTrials.gov

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