A pilot study of a novel, biodegradable, polymeric vitreous substitute for post-operative retinal tamponade

Pykus Therapeutics Inc.0 个研究点目标入组 7 人开始时间: 2021年7月27日最近更新: 2023年2月6日

适应症

试验速览

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•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.

•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

发起方

Pykus Therapeutics Inc.