A prospective surgical study evaluating the safety and tolerability of a novel, biodegradable retinal sealant (PYK-2101) following vitrectomy for retinal detachment repair

Pykus Therapeutics Inc.0 个研究点目标入组 10 人开始时间: 2024年9月27日最近更新: 2024年9月30日

适应症

试验速览

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•1.Age 18 or older of any gender2.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

•1.Pregnancy or breastfeeding2.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 acetazolamide7.Any condition or circumstance that, in the opinion of the surgeon investigator, would compromise the safety of the subject or the quality of study data8.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 studyIntraoperative Exiting CriteriaIf 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 retina2.Presence of proliferative vitreoretinopathy (PVR), need to create a retinectomy, or retinal breaks larger than one clock hour3.No more than 6 retinal breaks in total are permitted; breaks in any quadrant are permitted4.Significant intraoperative retinal and/or choroidal bleeding5.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

发起方

Pykus Therapeutics Inc.