None listed
Conditions
Brief summary
The purpose of this research project is to provide a new alternative to currently approved methods of sealing retinal breaks for participants that are undergoing repair of retinal detachments. The name of the investigational product in this study is PYK-2101. PYK-2101 will be injected during surgery as a retinal sealant to tears/breaks in the retina. Use of the investigational product will prevent subjects from having to remain in a face down position for a number of days, will not limit their ability for air travel for a period of time, nor require an additional surgery to remove the tamponade and may have improved visual clarity as compared to other methods.
Interventions
PYK-2101 is a novel retinal sealant to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-2101 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite and is a single use (single surgery) intervention.. During the vitrectomy (typically about a 30 minute procedure), after all retinal breaks have been treated, the investigational product is prepared and is then admin
PYK-2101 is a novel retinal sealant to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-2101 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite and is a single use (single surgery) intervention.. During the vitrectomy (typically about a 30 minute procedure), after all retinal breaks have been treated, the investigational product is prepared and is then administered via a cannula similar to what is already used routinely in retina surgery. The surgeon will apply a focused, micro delivery of gel to the site of retinal breaks so that all of the retinal breaks are completely covered which allows for a minimal amount of product. The application process is less than 5 minutes of the 30 minute procedure. This is a single use/dose product. a maximum volume administered will be 0.2mL. The surgeon and investigational team will follow the procedure as described in the protocol and Instructions For Use. They will be trained in use prior to site activation and prior to participant enrollment which is minimally one week in advance of treatment. This is a single one hour training provided by members of the Pykus Therapeutics team. The training is a combination of live in-in person, and video provided training. The site has had previous experience in the preparation and application of hydrogel, however this is a new formulation. The device is anticipated to biodegrade at approximately 6 weeks.. Compliance is assessed via objective imaging during the treatment (surgical video) and post-operative day one via Slit-lamp assessement with dilated funduscopy; wide-field color fundus photography, Macular SD-OCT. .
Sponsors
Pykus Therapeutics Inc.
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older of any gender 2. Undergoing vitrectomy for repair of primary rhegmatogenous retinal detachment with no more than 6 retinal breaks in total a. Primary detachment refers to rhegmatogenous detachment that occurs in a previously uninvolved eye without any complicating factors (e.g., proliferative vitreoretinopathy or penetrating trauma) 3. Phakic or pseudophakic 4. Willing to participate in the study as evidenced by signing of an informed consent document
Exclusion criteria
1. Pregnancy or breastfeeding 2. Known allergy to Hyaluronic Acid (HA); or Polyethylene Glycol (PEG) 3. Aphakic 4. Any prior history of uveitis, or other inflammatory or rheumatologic disease 5. A history of neovascularization of the iris (NVI) or the angle (NVA) 6. Known contraindication to using topical glaucoma drops or oral acetazolamide 7. Any condition or circumstance that, in the opinion of the surgeon investigator, would compromise the safety of the subject or the quality of study data 8. Participation in any clinical study of an investigational product within 30 days prior to enrollment, or any other planned eye surgery during the course of the study Intraoperative Exiting Criteria If any of the following are observed prior to attempted use of the investigational device, the subject will not receive the device and will be exited from the study: 1. Inability to flatten the retina 2. Presence of proliferative vitreoretinopathy (PVR), need to create a retinectomy, or retinal breaks larger than one clock hour 3. No more than 6 retinal breaks in total are permitted; breaks in any quadrant are permitted 4. Significant intraoperative retinal and/or choroidal bleeding 5. Any condition, intraoperative complication, or circumstance that in the opinion of the surgeon investigator, would compromise the safety of the subject, or the quality/interpretation of study data
Outcome results
None listed