[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Ocular Therapeutix, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":69},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632626","phase-3-study-to-evaluate-long-term-safety-of-intravitreal-otx-tki-axitinib-implant-in-participants-with-neovascular-age-related-macular-degeneration-who-successfully-completed-2-year-otx-tki-2023-amd-301-or-otx-tki-2023-amd-303-study-100632626",false,"NCT07516132","Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study","A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study","Inclusion Criteria:\n\n* Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96\n* Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging\n* Are able and willing to comply with all study requirements and visits\n* Have provided written informed consent\n\nExclusion Criteria:\n\n* Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1\n* History of intraocular inflammation in the study eye\n* Have evidence of a rhegmatogenous retinal detachment or visually significant\u002Fsevere epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular\n* Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results\n* Female participants who are pregnant (had a positive urine test at the Baseline visit \\[Day 1\\]) or breastfeeding or intend to become pregnant during the study, who are unwilling to use 2 forms of highly effective contraception from baseline until they exit the study or at least 3 months after the last study treatment, whichever is later.","ALL","50 Years",{"count":19,"type":20},850,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants with Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study",[26],"Neovascular Age-Related Macular Degeneration (nAMD)",[28,29,30],"Neovascular Age-Related Macular Degeneration","Tyrosine Kinase Inhibitor","OTX-TKI","RECRUITING","2026-06-29",{"date":34,"type":35},"2026-07-01","ACTUAL",{"date":37,"type":35},"2026-04-27",{"date":39,"type":20},"2030-08-01",{"name":41,"class":42},"Ocular Therapeutix, Inc.","INDUSTRY",8,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100611015","phase-3-a-study-to-evaluate-the-efficacy-and-safety-of-otx-tki-axitinib-implant-in-participants-with-non-proliferative-diabetic-retinopathy-100611015","NCT07235085","A Study to Evaluate the Efficacy and Safety of OTX-TKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy","A Phase 3, Multicenter, Double-Masked, Randomized, 3-Arm Parallel Group Study to Evaluate the Efficacy and Safety of Intravitreal OTXTKI (Axitinib Implant) in Participants With Non-Proliferative Diabetic Retinopathy","HELIOS-3","Inclusion Criteria:\n\n1. Male or female who is at least 18 years of age at the time of signing the informed consent form (ICF)\n2. History of or newly diagnosed with type 1 or 2 diabetes mellitus and have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the Central Reading Center (CRC) based on the images obtained at the Screening visit\n3. BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of ≥ 69 letters (approximate Snellen equivalent of 20\u002F40 or better) in the study eye\n4. Willing and able to comply with clinic visits and study-related procedures\n5. Provide signed informed consent\n\nExclusion Criteria:\n\n1. Presence of center-involved diabetic macular edema (CI-DME) defined per protocol via optical coherence tomography (SD-OCT) in the study eye, obtained at the Screening visit\n2. Evidence of a rhegmatogenous retinal detachment or visually significant\u002Fsevere epiretinal membrane, vitreomacular traction syndrome, macular hole, tear of the retinal pigment epithelium in the macula, or other macular pathology in the study eye deemed visually significant by the Investigator\n3. In the study eye, any panretinal photocoagulation (PRP) treatment prior to baseline, or received focal or grid laser photocoagulation within 1000 microns of the central subfield of the macula within 6 months prior to baseline\n4. IVT anti-VEGF treatment in the study eye within 6 months or port delivery system (PDS) with ranibizumab in the study eye at any time prior to baseline (Day 1)\n5. (There are additional exclusion criteria)","18 Years",{"count":54,"type":20},930,[23],"The purpose of this trial is to study the safety and effectiveness of OTX-TKI (axitinib intravitreal hydrogel) for the treatment of Non-Proliferative Diabetic Retinopathy.\n\nOTX-TKI is an intravitreal hydrogel embedded with axitinib. When the OTX-TKI hydrogel is administered into the vitreous cavity of the eye, the hydrogel begins to slowly break down, which allows the axitinib to be slowly released over time.\n\nThis clinical trial is comparing OTX-TKI to a \"sham\" injection procedure. The sham injection is a mock injection procedure, but nothing will actually be inserted in the eye as there is no needle on the sham injector. Only one eye (\"study eye\") will be treated with study treatment.",[58],"Non-Proliferative Diabetic Retinopathy",[58],"2026-03-12",{"date":62,"type":35},"2026-03-16",{"date":64,"type":35},"2025-11-17",{"date":66,"type":20},"2027-03",{"name":41,"class":42},1,""]