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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVC with tPA for CRVO | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 10 min |
| number of intervention-related surgical complications | These exist of the intra-operative occurence of:
| 7 days |
| duration of infusion | The time of infusion measured during surgery with a maximum of 10 minutes | 10 minutes |
| number of intervention-related non-surgical complications | The postoperative occurence of:
| 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| change in visual acuity after 6 to 8 weeks | best corrected visual acuity tested with ETDRS chart | 6-8 weeks |
| change in central macular thickness after 6 to 8 weeks | measurement of central macular thickness with spectral domain-OCT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Stalmans | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitaire Ziekenhuizen Leuven | Leuven | 3000 | Belgium |
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| ID | Term |
|---|---|
| D012170 | Retinal Vein Occlusion |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D020246 | Venous Thrombosis |
| D013927 | Thrombosis |
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| ID | Term |
|---|---|
| D014821 | Vitrectomy |
| D010959 | Tissue Plasminogen Activator |
| D007262 | Infusions, Intravenous |
| ID | Term |
|---|---|
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
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|
| Intravenous Infusion | Drug | Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml). |
|
|
| 6-8 weeks |
| intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA | - complications of intraocular surgery:
| 7 days |
| intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA | - complications during cataract surgery:
| 7 days |
| intra-/postoperative complications not related to the surgical stabilizer / retinal vein cannulation / rtPA | - complications during vitrectomy:
| 7 days |
| change in retinal flow intraoperatively visualized with OCT-angiography | 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. | 1 hour |
| D016769 |
| Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
| D061605 | Administration, Intravenous |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007263 | Infusions, Parenteral |