Central Retinal Vein Occlusion
Conditions
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).
Interventions
PROCEDUREVitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.
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..
DRUGIntravenous Infusion
Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 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) |
| duration of infusion | 10 minutes | The time of infusion measured during surgery with a maximum of 10 minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in visual acuity after 6 to 8 weeks | 6-8 weeks | best corrected visual acuity tested with ETDRS chart |
| change in central macular thickness after 6 to 8 weeks | 6-8 weeks | measurement of central macular thickness with spectral domain-OCT |
| intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA | 7 days | \- complications of intraocular surgery: * wound leak tested with concentrated fluorescein (Seidel effect present/absent) * endophthalmitis as seen with the slit lamp/ultrasonography * post-operative macular edema objectivated with OCT imaging * vitreous hemorrhage \> 2 weeks after intervention as seen at the slit lamp and confirmed with ultrasonography * development of neovascularization as seen at the slit lamp / fluorescein angiogram |
| 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. |
Countries
Belgium
Outcome results
None listed