[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"proliferative-vitreoretinopathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:proliferative-vitreoretinopathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,41,68,96,123,145],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100548778","phase-1-the-safety-and-efficacy-of-intravitreal-topotecan-for-the-treatment-of-proliferative-vitreoretinopathy-100548778",false,"NCT06425419","The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy","Inclusion Criteria:\n\n* Patients \\> 18 years old\n* Patients presenting with retinal detachment due with PVR (grade C or higher) or retinal detachment associated with open globe trauma\n* Patients undergoing vitrectomy or vitrectomy with scleral buckle as part of standard care.\n\nExclusion Criteria:\n\n* Patient unable to give consent\n* Patient unable to follow-up\n* Females of childbearing age who are pregnant at the time of recruitment. A pregnancy test will be done to all women of ages 18-55 prior to surgery to ensure they are not pregnant at the time of recruitment.\n* Patients with a history of tractional or exudative retinal detachment.\n* Patients with other planned ocular surgery following PPV\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in the operative eye\n* Signs of ocular infection at presentation in either eye\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* No Light Perception vision in the operative eye\n* Failure to achieve intraoperative reattachment\n* Patient with silicone oil instilled in the operative eye at time of presentation",true,"ALL","18 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy (PVR) or resulting from an open globe injury, and compare the outcomes to those who do no receive intravitreal topotecan. The main objectives it aims to achieve are:\n\n* to study the safety profile of intravitreal topotecan in the treatment of PVR\n* to evaluate the efficacy of intravitreal topotecan in treating PVR.\n\nPost-consent, participants will:\n\n* undergo vitrectomy (with or without scleral buckle) as part of standard treatment for retinal detachment.\n* receive intravitreal topotecan at the time of surgery, post-operative day 7 and post-operative day 28 (if randomized to receive the medication)\n* come in at post-operative day 1, 7, 28, 56, 84, 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula, have their intraocular pressure and visual acuity measured and their adverse events monitored, if any.\n\nResearchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment, rate of retinal reattachment and PVR grade 6 months after surgery.",[26,27,28],"Proliferative Vitreoretinopathy","Proliferative Vitreo-Retinopathy","Rhegmatogenous Retinal Detachment","NOT_YET_RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-02","ACTUAL",{"date":35,"type":20},"2026-09-01",{"date":37,"type":20},"2028-09-01",{"name":39,"class":40},"Massachusetts Eye and Ear Infirmary","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":49,"studyType":50,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100622673","study-of-imaging-and-molecular-biomarkers-in-uncomplicated-rhegmatogenous-retinal-detachment-100622673","NCT07386678","Study of Imaging and Molecular Biomarkers in Uncomplicated Rhegmatogenous Retinal Detachment","Cohort-NHS","Inclusion Criteria:\n\n* Adults ≥18 years\n* Uncomplicated primary rhegmatogenous retinal detachment\n* PVD present\n* No PVR-A\u002FB\u002FC\n* Phakic or pseudophakic.\n\nExclusion Criteria:\n\n* Patients \\\u003C18 years\n* Patients lacking capacity\n* Previous vitrectomy\n* Previous cryopexy\n* Aphakia\n* No fundal view\n* Diabetic retinopathy of any severity\n* Retinal detachment secondary to infective causes e.g. acute retinal necrosis, toxoplasmosis scars\n* Retinal detachment secondary to congenital defects e.g. optic disc pit\u002Fcoloboma\n* Exudative retinal detachment\n* Tractional retinal detachment\n* Ongoing involvement in another ocular trial.",{"count":19,"type":20},"3 Months","OBSERVATIONAL","Disease or general study area: Uncomplicated rhegmatogenous retinal detachment (RRD) and risk of proliferative vittroretinopathy (PVR)\n\nPurpose and nature of the study:\n\n1. Characterise the cytokine profile of vitreous fluid in uncomplicated RRD.\n2. Develop a risk model to predict development of PVR after retinal detachment surgery using imaging and molecular biomarkers.\n3. To develop deep learning\u002Fartificial intelligence (AI) models for PVR detection in retinal detachment.\n\nInclusion criteria:\n\n50 adult ( ≥18 years) patients with uncomplicated rhegmatogenous retinal detachments without PVR.\n\nWhat participating will involve:\n\nPre- and post-operative assessments and intervention will follow standard of care for patients with rhegmatogenous retinal detachments.\n\nAdditional intervention will include non-invasive imaging of anterior chamber flare, vitreous, wide-field retina, macula optical coherence tomography (OCT) and macula OCT-angiography (OCT-A) as well as, seeking participant's consent on collecting their vitreous fluid at time of their surgery for cytokine analysis.",[53,26,54],"Retinal Detachment Rhegmatogenous","Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment",[56,57],"Cytokines","Imaging","2026-05-05",{"date":60,"type":33},"2026-05-06",{"date":62,"type":20},"2026-04-27",{"date":64,"type":20},"2027-01-27",{"name":66,"class":40},"University College, London",1,{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":79,"conditions":80,"keywords":81,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":67},"100518681","phase-1-topical-netarsudil-for-the-prevention-of-proliferative-vitreoretinopathy-in-patients-with-retinal-detachment-100518681","NCT06033703","Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment","Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Primary Rhegmatogenous Detachments and Retinal Detachment Due to Proliferative Vitreoretinopathy or Open-Globe Injury: A Phase I\u002FII Clinical Trial","The primary rhegmatogenous detachment cohort will have the following selection criteria:\n\nInclusion criteria:\n\n* Patients \\> 18 years old\n* Patients presenting for primary rhegmatogenous retinal detachment repair within 28 days of symptom onset\n* Patients undergoing vitrectomy or vitrectomy with scleral buckle\n\nExclusion criteria:\n\n* Patient unable to give consent\n* Patient unable to follow-up\n* Prior history of retinal detachment incisional surgery in presenting eye\n* Prior history of open globe injury to presenting eye\n* Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery, actively on glaucoma medication\n* Prior history of corneal disease, or history of corneal edema\n* Patient already on topical netarsudil in presenting eye\n* Patient without natural lens or intraocular lens implant (I.e., aphakic patients)\n* Patients with intraocular pressure \\\u003C8mm Hg in operative eye\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Diagnosis of proliferative diabetic retinopathy\n* Signs of ocular infection at presentation in either eye\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* Inability to use\u002F apply topical eye drops\n\nThe proliferative vitreoretinopathy cohort will have the following selection criteria:\n\nInclusion criteria:\n\n* Patients \\> 18 years old\n* Patient presenting with retinal detachment due with proliferative vitreoretinopathy (grade C or higher) or retinal detachment associated with open globe trauma\n* Patients undergoing vitrectomy or vitrectomy with scleral buckle\n\nExclusion criteria:\n\n* Patient unable to give consent\n* Patient unable to follow-up\n* Prior history of glaucoma surgery to presenting eye I.e., Status post trabeculectomy, Ahmed tube placement, minimally invasive glaucoma surgery\n* Patient already on topical netarsudil in presenting eye\n* Patients with intraocular pressure \\\u003C8mm Hg in operative eye\n* Active or chronic or recurrent uncontrolled ocular or systemic disease\n* Active or history of chronic or recurrent inflammatory eye disease\n* Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in operative eye\n* Signs of ocular infection at presentation in either eye\n* Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively\n* Inability to use\u002F apply topical eye drops\n* No Light Perception vision in operative eye\n* Failure to achieve intraoperative reattachment",{"count":76,"type":20},48,[23,78],"PHASE2","This study has two main objectives. The first objective is to study the pharmacokinetics of topical netarsudil administration in the posterior segment of the eye, where netarsudil must exert its effect in order to prevent formation of tractional membranes.\n\nThe second objective is to assess the safety profile of topical netarsudil in the pre- and post-operative periods. A secondary objective of the study is to begin to assess signs of efficacy in preventing formation of tractional membranes post-operatively.",[28,26],[82,83,84,85,86],"Vitrectomy","Netarsudil","Pharmacokinetics","Safety","Efficacy","RECRUITING","2025-10-24",{"date":90,"type":33},"2025-10-28",{"date":92,"type":33},"2025-01-14",{"date":94,"type":20},"2026-12",{"name":39,"class":40},{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":106,"briefSummary":107,"conditions":108,"keywords":109,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":122},"100579009","phase-2-intravitreal-topotecan-for-prevention-or-treatment-of-proliferative-vitreoretinopathy-in-retinal-detachment-100579009","NCT06818721","Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment","Intravitreal Topotecan for the Prevention or Treatment of Proliferative Vitreoretinopathy in Patients with Rhegmatogenous Retinal Detachment: a Prospective Matched Cohort Study","TOPO-PT","Inclusion Criteria:\n\n1. Patients aged 18 years and older\n2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and\u002For scleral buckling for rhegmatogenous retinal detachment\n3. Patients who are voluntarily able and willing to participate\n\nPatients undergoing combined phacoemulsification and pars plana vitrectomy and\u002For scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.\n\nExclusion Criteria:\n\n1. Patients with a history of exudative retinal detachment\n2. Patients with severe non-proliferative or proliferative diabetic retinopathy\n3. Patients with other planned ocular surgery following pars plana vitrectomy\n4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study\n5. Patients with pre-existing bone marrow suppression or cytopenias\n6. Patients with pre-existing interstitial lung disease",{"count":105,"type":20},394,[78],"Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.",[53,26],[110,111,112],"topotecan","proliferative vitreoretinopathy","rhegmatogenous retinal detachment","2025-03-03",{"date":115,"type":33},"2025-03-06",{"date":117,"type":20},"2025-03",{"date":119,"type":20},"2027-04",{"name":121,"class":40},"Unity Health Toronto",2,{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":130,"targetDuration":4,"studyType":21,"phases":132,"briefSummary":133,"conditions":134,"keywords":135,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":67},"100557704","phase-2-prevention-of-proliferative-vitreoretinopathy-with-intravitreal-methotrexate-in-primary-retinal-detachment-repair-fixer-trial-100557704","NCT06541574","Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial","FIXER","Inclusion Criteria:\n\n• Any adult patient, age \\> 18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent.\n\nExclusion Criteria:\n\n* Age \\<18 years-old\n* Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit.\n* History of endophthalmitis, ruptured globe or significant trauma in the affected eye\n* Chronic retinal detachment (symptoms \\> six weeks)\n* Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded.\n* Presence of Grade C PVR: full thickness retinal folds or subretinal bands\n* Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate\n* Patients with diminished mental capacity precluding their ability to give informed consent.",{"count":131,"type":20},860,[78],"I. Title Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial\n\n* Today's Date: September 18, 2023 II. Principal Investigator\n* Principal Investigator: Christopher D. Riemann, M.D. (Cincinnati Eye Institute)\n* Email: criemann@cvphealth.com, Phone: 513-708-1979\n\nV. Research Summary\n\nPurpose:\n\nTo evaluate methotrexate for the prevention of PVR after primary rhegmatogenous retinal detachment repair.\n\nMethods:\n\nInclusion Criteria:\n\n• Any adult patient, age ≥18 years-old, undergoing primary rhegmatogenous retinal detachment surgery with pars plana vitrectomy at the Cincinnati Eye Institute in Blue Ash, Ohio who is able to give informed consent.\n\nExclusion Criteria:\n\n* Age \\<18 years old\n* Pregnant patients or patients of child bearing potential unwilling to utilize long term contraception for the 12-week period spanning vitrectomy surgery for retinal detachment repair up until the 3 month postoperative visit.\n* History of endophthalmitis, ruptured globe or significant trauma in the affected eye\n* Chronic retinal detachment (symptoms greater than or equal to six weeks)\n* Any previous previous retinal detachment repair with pars plana vitrectomy, or scleral buckling surgery. Patients having undergone previous pneumatic retinopexy will not be excluded.\n* Presence of Grade C PVR: full thickness retinal folds or subretinal bands\n* Patients with contraindications to methotrexate, including breastfeeding, pregnancy, attempting to conceive a child or any known hypersensitivity or intolerance to methotrexate\n* Patients with diminished mental capacity precluding their ability to give informed consent.\n\nStudy Design and Randomization This prospective double masked trial will randomize patients into four groups in a 1:1:1:1 fashion. All attending surgeons and patients will be masked to group randomization. Randomization into four groups will occur on the day of surgery by the Cincinnati Eye Institute's pharmacist, Deepali Chachare. Group A will consist of ≥ 150 patients receiving intraoperative infusion with balanced salt solution containing methotrexate (40mg\u002F500mL BSS), and methotrexate intravitreal injections (400mcg\u002F0.05mL) at postoperative weeks 1, 3, 6, and 10. Group B will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion containing methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10. Group C will consist of ≥ 150 patients receiving a balanced salt solution infusion without methotrexate, and methotrexate injections at postoperative weeks 1, 3, 6, and 10. Group D will consist of ≥ 150 patients receiving intraoperative balanced salt solution infusion without methotrexate, and sham intravitreal injections at postoperative weeks 1, 3, 6, and 10.",[26,28],[26,28],"2024-09-05",{"date":138,"type":33},"2024-09-19",{"date":140,"type":33},"2024-03-01",{"date":142,"type":20},"2026-06",{"name":144,"class":40},"Cincinnati Eye Institute, Southwest Ohio",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":21,"phases":155,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":160,"lastUpdatePostDateStruct":161,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":4},"100480605","internal-limiting-membrane-peeling-in-retinal-detachment-surgery-100480605","NCT05538156","Internal Limiting Membrane Peeling in Retinal Detachment Surgery","Internal Limiting Membrane Peeling in Macula-off Retinal Detachment With Grade B Proliferative Vitreoretinopathy","IMPURITY","Inclusion Criteria:\n\n* Patients older than 18 years old\n* With macula-off retinal detachment complicated by grade B proliferative vitreoretinopathy\n\nExclusion Criteria:\n\n* Underage patients\n* History of retinal detachment\n* History of intraocular surgery (except for cataract surgery)\n* Traumatic retinal detachment\n* Macular hole-associated retinal detachment\n* Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)",{"count":154,"type":20},126,[156],"NA","Despite advances in surgical techniques over the recent decades, proliferative vitreoretinopathy (PVR) remains the main obstacle to successful rhegmatogenous retinal detachment (RRD) repair, accounting for nearly 75% of all primary surgical failures. It is characterized by the growth and contraction of cellular membranes within the vitreous cavity and on both surfaces of the detached retina as well as intraretinal fibrosis.\n\nThe Retina Society classification, modified in 1991 and currently the most widely used, divided PVR into three grades. Grade A is limited to the presence of vitreous haze and pigment clumps. Grade B includes rolled or irregular edges of tear and\u002For inner retinal surface wrinkling with possible retinal stiffness and vessel tortuosity. Grade C is defined as the presence of full-thickness fixed retinal folds and is further subdivided based on the number of hours involved and the location.\n\nRecently, Foveau et al., in a retrospective comparative case series, have demonstrated that performing internal limiting membrane (ILM) peeling during RRD surgery may increase the anatomical success rate for this indication.\n\nThe aim of this multi-center, prospective, randomized controlled clinical trial study is to evaluate the effectiveness of ILM peeling on surgical outcomes in patients with primary macula-off RRD complicated by grade B PVR.",[159,26],"Retinal Detachment","2022-09-09",{"date":162,"type":33},"2022-09-13",{"date":164,"type":20},"2022-09",{"date":166,"type":20},"2027-12",{"name":168,"class":40},"Central Hospital, Nancy, France"]