[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584633":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":39,"centralContacts":39,"locations":40,"responsibleParty":76,"collaborators":39,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":39,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":39,"enrollmentInfo":87,"targetDuration":39,"studyType":90,"phases":91,"briefSummary":94,"conditions":95,"keywords":39,"overallStatus":43,"whyStopped":39,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"Sumitomo Pharma America, Inc.","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Cohort 1","EXPERIMENTAL","Best Corrected Visual Acuity (BCVA) in the study eye between hand motion and 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≤ 20\u002F400 Snellen equivalent), inclusive at Screening and Baseline",[13],"Drug: DSP-3077 Retinal Sheet Cohort 1",{"label":15,"type":10,"description":11,"interventionNames":16},"Cohort 2",[17],"Drug: DSP-3077 Retinal Sheet Cohort 2",{"label":19,"type":10,"description":20,"interventionNames":21},"Cohort 3","Best Corrected Visual Acuity (BCVA) in the study eye between 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letter score (approximately ≥ 20\u002F400 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20\u002F200 Snellen equivalent), inclusive at Screening; BCVA in the study eye between 10 ETDRS letter score (approximately ≥ 20\u002F640 Snellen equivalent) and 35 ETDRS letter score (approximately ≤ 20\u002F200 Snellen equivalent) at Baseline",[22],"Drug: DSP-3077 Retinal Sheet Cohort 3",[24,30,35],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","DSP-3077 Retinal Sheet Cohort 1","For each participant only 1 eye will receive a low dose (\\>= 0.8 to \\\u003C 2.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1",[9],[9],{"type":25,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DSP-3077 Retinal Sheet Cohort 2","For each participant only 1 eye will receive a high dose (\\>= 2.4 to \\\u003C 6.4 mm2) of single subretinal injection of DSP-3077 using the DSP-3077-delivery device on Day 1",[15],[15],{"type":25,"name":36,"description":32,"armGroupLabels":37,"otherNames":38},"DSP-3077 Retinal Sheet Cohort 3",[19],[19],null,[41,61],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Massachusetts Eye and Ear","RECRUITING","Boston","Massachusetts","02114","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-71.05977,42.35843,{"lat":53,"lon":52},[56],{"name":57,"role":58,"phone":59,"phoneExt":39,"email":60},"Albert Cheng","CONTACT","617-573-6060","acheng18@meei.harvard.edu",{"facility":62,"status":43,"city":63,"state":64,"zip":65,"country":47,"countryCode":48,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"University of Minnesota","Minneapolis","Minnesota","55455",{"type":50,"coordinates":67},[68,69],-93.26384,44.97997,{"lat":69,"lon":68},[72],{"name":73,"role":58,"phone":74,"phoneExt":39,"email":75},"Jacob Stauffer","612-625-4108","jstauffe@umn.edu",{"type":77,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR","100584633","phase-1-a-study-to-investigate-the-safety-of-dsp-3077-after-a-unilateral-eye-injection-in-male-and-female-participants-18-years-of-age-or-older-with-retinitis-pigmentosa-100584633",false,"NCT06891885","A Study to Investigate the Safety of DSP-3077 After a Unilateral Eye Injection in Male and Female Participants 18 Years of Age or Older With Retinitis Pigmentosa","A Prospective, Open-label, Single-arm, Dose-escalation Study of the Safety and Tolerability of a Single Subretinal Uniocular Injection of Allogeneic Induced Pluripotent Stem Cell (iPSC)-Derived Retinal Sheets (DSP-3077) in Adults With Retinitis Pigmentosa (RP)","Inclusion Criteria:\n\n* Participant is \\>= 18 years of age at the time of signing the informed consent.\n* Participant has a clinical diagnosis of nonsyndromic retinitis pigmentosa.\n* Participant is willing to consent to genetic testing, if not already done.\n* Cohorts 1 and 2: Participant will have BCVA in the study eye between hand motion and 20 ETDRS letter score (approximately \\\u003C= 20\u002F400 Snellen equivalent), inclusive at Screening and Baseline.\n* Cohort 3: Participant will have BCVA in the study eye between 20 ETDRS letter score (approximately \\>= 20\u002F400 Snellen equivalent) and 35 ETDRS letter score (approximately \\\u003C= 20\u002F200 Snellen equivalent), inclusive at Screening.\n* Participant is in good physical health, based on medical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory tests at Screening.\n\nExclusion Criteria:\n\n* Participant has an eye disease or visual disorder other than RP that impairs visual function (eg, retinal vascular disease, glaucoma).\n* Participant has any other eye condition (eg, ocular media opacity, nystagmus), which in the opinion of the investigator, would preclude an accurate evaluation at any time during the study and\u002For make surgical delivery more challenging.\n* Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the investigator, would limit the participant's ability to complete and\u002For participate in the study.\n* Female participant who is pregnant or lactating or planning to become pregnant.\n* Participant has received treatment with any nonapproved, experimental, or investigational therapy in either eye (systemic, topical, intravitreal) and\u002For received treatment in an interventional clinical trial for an eye disease or disorder within 90 days or 5 half-lives, whichever is longer, prior to Screening.\n* Participant has previously received cell therapy, gene augmentation therapy, genome editing therapy, or any subretinal administered therapy for an eye disease or disorder.","ALL","18 Years",{"count":88,"type":89},12,"ESTIMATED","INTERVENTIONAL",[92,93],"PHASE1","PHASE2","The Goal of this study is to evaluate the safety, tolerability, and clinical responses following single dose of DSP-3077. Study enrolls both male and female patients in 3 cohorts with each cohort defined by visual acuity (VA) criteria and dose level of DSP-3077. Each cohort will include 4 participants.",[96],"Retinitis Pigmentosa","2026-04-14",{"date":99,"type":100},"2026-04-17","ACTUAL",{"date":102,"type":89},"2026-04-16",{"date":104,"type":89},"2032-10-31",{"name":5,"class":6},2]