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 (retinal tamponade) and substitute for the liquid portion (vitreous) of your eye. Tamponade is a required action for the standard surgery required for retinal detachment repair. The name of the investigational product in this study is PYK-1105. PYK-1105 will be injected during surgery as a vitreous substitute and tamponade. 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-1105 is a novel retinal tamponade and vitreous substitute to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-1105 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite. During the vitrectomy, 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 i
PYK-1105 is a novel retinal tamponade and vitreous substitute to be utilized in conjunction with vitrectomy in the repair of retinal detachment. PYK-1105 is an investigational product, a hydrogel, provided by Pykus Therapeutics to the selected investigators (ophthalmic surgeons) for use in the surgical suite. During the vitrectomy, 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. This is a single use/dose product. Approximately 0.02-0.15 mL will be applied in total. The product is expected to naturally degrade within 2-4 weeks. Compliance will be confirmed through review of the surgical record and post operative imaging.
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
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 21 or older of any gender 2. No plan for simultaneous phacoemulsification (e.g. phaco-vit) or lensectomy 3. At least LogMAR BCVA 1.3 (Snellen equivalent 20/400) or worse in the affected eye 4. At least LogMAR BCVA 0.3 (Snellen equivalent 20/40) or better in the unaffected eye and no active significant ocular disease (such as proliferative diabetic retinopathy or advanced glaucoma) that may result in future loss of vision 5. Phakic, pseudophakic, or aphakic 6. Undergoing vitrectomy for repair of rhegmatogenous or tractional-rhegmatogenous retinal detachment 7. Evidence of poor visual prognosis in the operative eye i. Poor visual prognosis may include but is not limited to: history of poor baseline vision (20/100 vision or worse), history of a macula-off detachment of more than 6 weeks duration, history of multiple recurrent retinal detachments, history of macular ischemia, presence of combined tractional-rhegmatogenous detachment, history of retinal detachment associated with endophthalmitis/infectious retinitis that is now inactive, history of retinal detachment associated with open globe injury, or other concomitant ocular condition, which in the opinion of the surgeon investigator, would preclude a visual recovery to an ambulatory level (>20/100) if conventional tamponade methods were used. 8. 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 PVA or PEG 3. Presence of significant pre-existing corneal disease (e.g. history of corneal dystrophy, history of corneal transplant, history of non-healing epithelial defect) 4. A history of uveitis, or a history of any other inflammatory or rheumatologic disease (not including inactive endophthalmitis or retinitis) 5. A history of glaucoma, glaucoma suspect, ocular hypertension (baseline IOP greater than 20mm Hg), ongoing use of IOP lowering agents, or prior use of IOP lowering agents 6. Narrow anatomical angles or presence of neovascularization of the iris (NVI) or the angle (NVA) 7. Known contraindication to using topical glaucoma drops or oral acetazolamide 8. Presence of an optic pit 9. More than one clock hour of Grade C proliferative vitreoretinopathy (PVR) 10. 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 11. Participation in any clinical study of an investigational product within 30 days prior to enrollment Exclusion Criteria - Intraoperative 12. Inability to completely flatten the retina 13. Significant retinal bleeding 14. Any condition, intraoperative complication, or circumstance that in the opinion of the surgeon investigator, would compromise the safety of the subject or the quality of study data
Outcome results
None listed