Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347107
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-03-21
Brief Title:
Robotic Subretinal tPA Injection Study
Sponsor:
Universitaire Ziekenhuizen KU Leuven
Organization:
Universitaire Ziekenhuizen KU Leuven
Study Overview
Official Title:
Robotic Subretinal tPA Injection Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RoTIS
Brief Summary:
In the RoTIS study the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery The surgical devices used during this procedure will be the following
The robotic stabilizer prototype - FAMHP approval received
41G subretinal needle CE marked - used within label
Inicio micro-injection system CE marked - used within label The Inicio system mounted with the 41G needle will be held by the robot and guided by the surgeon towards the required position When the tip of the needle is in the desired subretinal position the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained with a maximal duration of up to 3 minutes
As performed routinely the surgical view through the microscope will be video-recorded and while the injection is being administered the built-in iOCT of the Artevo surgical microscope Zeiss Oberkochen Germany will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review
The robotic stabilizer prototype - FAMHP approval received
41G subretinal needle CE marked - used within label
Inicio micro-injection system CE marked - used within label The Inicio system mounted with the 41G needle will be held by the robot and guided by the surgeon towards the required position When the tip of the needle is in the desired subretinal position the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained with a maximal duration of up to 3 minutes
As performed routinely the surgical view through the microscope will be video-recorded and while the injection is being administered the built-in iOCT of the Artevo surgical microscope Zeiss Oberkochen Germany will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review
Detailed Description:
Age-related macular degeneration is a common disease in the elderly population In the atrophic form central retinal degeneration leads to the formation of central metamorphopsia or scotoma In 10 of all cases the atrophic form becomes proliferative whereby newly formed vessels grow under the macular area Although this proliferation can be controlled in most patients with intravitreal injections of anti-VEGF in some cases a subretinal hemorrhage occurs which causes a drastic drop in visual acuity
Before anti-VEGF treatment existed removal of the subretinal vessels followed by a macular translocation or transplantation of retinal pigment epithelium cells was sometimes considered in such cases when the second eye became affected 12
Later on when anti-VEGF and other growth inhibiting products became available Macugen Lucentis Avastin Eylea BeoVue ophthalmologistsdeveloped a far less invasive surgically technique to inject tPA subretinally into the blood clot using a 41G 011mm subretinal needle followed by an air fill of the vitreous cavity to displace the subretinal liquefied blood away from the macular area 34
Since the causal neovascular vessels are not removed during this procedure repeat injections with anti-VEGF or analogue products are mandatory afterwards to reduce the risk of recurring hemorrhage
This surgical technique typically consists of a standard three-port pars plana vitrectomy induction of posterior vitreous detachment if not already present core and peripheral vitrectomy EVA Nexus surgical system DORC Zuidland The Netherlands Macular detachment is induced by subretinal injection of a balanced salt solution BSS The injection device is a 41G polyimide straight subretinal cannula with 27G shaft DORC connected to the Inicio micro-injection system DORC The EVA Nexus surgical system the 41G subretinal needle and the Inicio micro-injection system used in this study are all CE-labeled devices and used on-label
This surgical technique has been previously described in the literature34 albeit performed using older generations surgical systems the Associate and EVA respectively DORC Zuidland The Netherlands In our department such surgical procedure with subretinal injection of tPA is performed about 25 times yearly
More recently gene therapy is being developed to treat several different congenital eye diseases In 2021 the first of such products became commercially available Luxturna Novartis All the gene therapy vehicles which are either already available or are being developed have in common that they need to be precisely subretinally injected in a very small volume For Luxturna application the standard-of-care is to manually hold the subretinal needle into the subretinal space and to ask the surgical assistant to manually inject the product under the retina while the surgeon holds still the subretinal needle It does not need to be explained that such surgical conditions are far from ideal to inject a product that costs Eur 375 000 per dose
A tool that would help the surgeon to eliminate hand-tremor and to hold still the subretinal needle in the subretinal space would be very much welcomed as adjunct in this type of surgery There is a robotic system available with the CE-mark for intra-ocular surgery Preceyes Eindhoven The Netherlands recently acquired by Zeiss Oberkochen Germany but this was developed as an aiding tool for intra-ocular membrane peeling Other systems are being developed but not yet commercially available eg Accusurgical Montpellier France or Foresight Robotics Yoknam Illit Israel
In 2017 after more than 10 years of development the investigators performed robot-assisted retinal vein cannulation with injection of Ocriplasmin during vitrectomy surgery in 4 patients to treat central retinal vein occlusion study S587825 For that study a robotic stabilizer was used that has two main functions while holding a surgical instrument
It removes high-frequency movements from the surgeons hand thereby offering a tremor-dampening feature
It can be locked when the tip of the instrument needle is in the desired position allowing a prolonged injection of liquid medication over several minutes while the tip remains in the same position It must be emphasized here that our robotic stabilizer is used as a co-manipulation system the surgical instrument is held by both the surgeon and the robot therefore guaranteeing that the surgeon has always has control and override possibility This in contrast with almost all other robots for eye surgery that are available or under development which are tele-manipulating devices In such device the surgeon holds joysticks to remotely control the robot that holds the surgical instrument similar to the Da Vinci system the well-known robot for more general surgery
During that cannulation study three devices were under investigation not CE-labeled
The robotic stabilizer
The study drug Ocriplasmin - Jetrea
The glass needle to penetrate the occluded retinal vein In all four patients of trial S58782 the investigators were able to successfully introduce the needle into the occluded vessel and to inject ocriplasmin for up to 9 minutes long while the robotic stabilizer held the needle in the vessel5
In the RoTIS study the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery The surgical devices used during this procedure will be the following
The robotic stabilizer prototype - FAMHP approval received
41G subretinal needle CE marked - used within label
Inicio micro-injection system CE marked - used within label The Inicio system mounted with the 41G needle will be held by the robot and guided by the surgeon towards the required position When the tip of the needle is in the desired subretinal position the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained with a maximal duration of up to 3 minutes
As performed routinely the surgical view through the microscope will be video-recorded and while the injection is being administered the built-in iOCT of the Artevo surgical microscope Zeiss Oberkochen Germany will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review
Before anti-VEGF treatment existed removal of the subretinal vessels followed by a macular translocation or transplantation of retinal pigment epithelium cells was sometimes considered in such cases when the second eye became affected 12
Later on when anti-VEGF and other growth inhibiting products became available Macugen Lucentis Avastin Eylea BeoVue ophthalmologistsdeveloped a far less invasive surgically technique to inject tPA subretinally into the blood clot using a 41G 011mm subretinal needle followed by an air fill of the vitreous cavity to displace the subretinal liquefied blood away from the macular area 34
Since the causal neovascular vessels are not removed during this procedure repeat injections with anti-VEGF or analogue products are mandatory afterwards to reduce the risk of recurring hemorrhage
This surgical technique typically consists of a standard three-port pars plana vitrectomy induction of posterior vitreous detachment if not already present core and peripheral vitrectomy EVA Nexus surgical system DORC Zuidland The Netherlands Macular detachment is induced by subretinal injection of a balanced salt solution BSS The injection device is a 41G polyimide straight subretinal cannula with 27G shaft DORC connected to the Inicio micro-injection system DORC The EVA Nexus surgical system the 41G subretinal needle and the Inicio micro-injection system used in this study are all CE-labeled devices and used on-label
This surgical technique has been previously described in the literature34 albeit performed using older generations surgical systems the Associate and EVA respectively DORC Zuidland The Netherlands In our department such surgical procedure with subretinal injection of tPA is performed about 25 times yearly
More recently gene therapy is being developed to treat several different congenital eye diseases In 2021 the first of such products became commercially available Luxturna Novartis All the gene therapy vehicles which are either already available or are being developed have in common that they need to be precisely subretinally injected in a very small volume For Luxturna application the standard-of-care is to manually hold the subretinal needle into the subretinal space and to ask the surgical assistant to manually inject the product under the retina while the surgeon holds still the subretinal needle It does not need to be explained that such surgical conditions are far from ideal to inject a product that costs Eur 375 000 per dose
A tool that would help the surgeon to eliminate hand-tremor and to hold still the subretinal needle in the subretinal space would be very much welcomed as adjunct in this type of surgery There is a robotic system available with the CE-mark for intra-ocular surgery Preceyes Eindhoven The Netherlands recently acquired by Zeiss Oberkochen Germany but this was developed as an aiding tool for intra-ocular membrane peeling Other systems are being developed but not yet commercially available eg Accusurgical Montpellier France or Foresight Robotics Yoknam Illit Israel
In 2017 after more than 10 years of development the investigators performed robot-assisted retinal vein cannulation with injection of Ocriplasmin during vitrectomy surgery in 4 patients to treat central retinal vein occlusion study S587825 For that study a robotic stabilizer was used that has two main functions while holding a surgical instrument
It removes high-frequency movements from the surgeons hand thereby offering a tremor-dampening feature
It can be locked when the tip of the instrument needle is in the desired position allowing a prolonged injection of liquid medication over several minutes while the tip remains in the same position It must be emphasized here that our robotic stabilizer is used as a co-manipulation system the surgical instrument is held by both the surgeon and the robot therefore guaranteeing that the surgeon has always has control and override possibility This in contrast with almost all other robots for eye surgery that are available or under development which are tele-manipulating devices In such device the surgeon holds joysticks to remotely control the robot that holds the surgical instrument similar to the Da Vinci system the well-known robot for more general surgery
During that cannulation study three devices were under investigation not CE-labeled
The robotic stabilizer
The study drug Ocriplasmin - Jetrea
The glass needle to penetrate the occluded retinal vein In all four patients of trial S58782 the investigators were able to successfully introduce the needle into the occluded vessel and to inject ocriplasmin for up to 9 minutes long while the robotic stabilizer held the needle in the vessel5
In the RoTIS study the investigators would like to test the robotic stabilizer for the subretinal injection of tPA in patients with subretinal hemorrhage during standard-of-care surgery The surgical devices used during this procedure will be the following
The robotic stabilizer prototype - FAMHP approval received
41G subretinal needle CE marked - used within label
Inicio micro-injection system CE marked - used within label The Inicio system mounted with the 41G needle will be held by the robot and guided by the surgeon towards the required position When the tip of the needle is in the desired subretinal position the robotic stabilizer will be locked and the tPA will be injected till sufficient subretinal bleb formation is obtained with a maximal duration of up to 3 minutes
As performed routinely the surgical view through the microscope will be video-recorded and while the injection is being administered the built-in iOCT of the Artevo surgical microscope Zeiss Oberkochen Germany will be used to scan the retina area around the injection site to record the subretinal bleb formation for later review
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None