[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06536491":3,"trial-entities:NCT06536491":83,"trial-summary:NCT06536491":88},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":26,"interventions":29,"primary_outcomes":42,"secondary_outcomes":47,"sex":51,"minimum_age":52,"maximum_age":53,"healthy_volunteers":15,"eligibility_criteria":54,"std_ages":58,"locations":61,"central_contacts":75,"overall_officials":80,"references":81,"see_also_links":82},"NCT06536491","EC104-CS-201","EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema","A Randomized, Controlled, Subject- and Evaluator-Masked, Phase 2 Clinical Trial Comparing EC-104 Intravitreal Implant to Ozurdex® for the Treatment of Diabetic Macular Edema (BETTIS-1)","RECRUITING","2025-12-31","2025-01","2025-01-22","2024-08-19","Eclipse Life Sciences, Inc.","INDUSTRY",false,"This is a prospective, randomized, subject- and evaluator-masked, Phase 2, multicenter study comparing the safety and efficacy of EC-104-6M high-dose (fluocinolone acetonide \\[FA\\] 0.14 mg) implant and EC-104-4M low-dose (FA 0.092 mg) implant to Ozurdex® (dexamethasone intravitreal (IVT) implant, 0.7 mg) in subjects with diabetic retinopathy (DR) and center-involving diabetic macular edema (DME), with prior suboptimal clinical response to IVT anti-VEGF therapy who have been previously treated with locally administered corticosteroids without a clinically significant rise in intraocular pressure (IOP).","Approximately 75 subjects who meet entry criteria will be randomized 1:1:1 to EC-104-6M high-dose (FA 0.14 mg) implant or EC-104-4M low-dose (FA 0.092 mg) implant or Ozurdex® (dexamethasone IVT implant 0.7 mg), with the goal of achieving approximately 20 subjects per group with a positive therapeutic response in their study eyes, who are evaluable in the primary endpoint analysis to assess efficacy. Subjects with a positive therapeutic response at Week 4 will be included in the primary and secondary endpoint analyses to assess efficacy for \"Time to recurrent disease.\" Subjects who do not achieve a positive therapeutic response will be classified as suboptimal responders. While suboptimal responders will not be included in the primary and the secondary endpoint analyses to assess efficacy for \"Time to recurrent disease,\" they will remain in the study and will be followed prospectively, with inclusion in the remaining endpoints to assess efficacy and all safety endpoint analyses",[19],"Diabetic Macular Edema",[],"INTERVENTIONAL","TREATMENT",[24,25],"PHASE1","PHASE2",{"count":27,"type":28},75,"ESTIMATED",[30,35,38],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","EC-104 high dose","Intravitreal injection",[32],{"type":31,"name":36,"description":33,"armGroupLabels":37},"EC-104 low dose",[36],{"type":31,"name":39,"description":40,"armGroupLabels":41},"Dexamethasone intravitreal implant","Marketed product intravitreal injection",[39],[43],{"measure":44,"description":45,"timeFrame":46},"Ocular and Systemic Safety","Incidence of Adverse events","Through Week 24",[48],{"measure":49,"description":50,"timeFrame":46},"Diabetic macular edema recurrence","Time (days) to recurrence","ALL","18 Years",null,{"inclusion":55,"exclusion":56,"raw_text":57},[],[],"Inclusion Criteria:\n\n1. Males or females who are at least 18 years of age at the time of informed consent\n2. Willing and able to provide signed informed consent (participant or legally authorized representative) prior to any study-related procedures and to comply with all study visits and cooperate with all examinations\n3. Diagnosis of diabetes mellitus (Type 1 or Type 2), with history of diabetic macular edema (DME) \\\u003C = years duration prior to Screening Visit 1\n4. Currently monitored hemoglobin A1c values ≤ 10.0 while under the care of a qualified medical provider for diabetes mellitus management, unless provider allows value variance\n\n   Inclusion criteria for the study eye (all of the below criteria must be met in the same eye):\n5. Early Treatment Diabetic Retinopathy Study BCVA score ≤ 70 letters (Snellen equivalent 20\u002F40 or worse) and ≥ 20 letters (Snellen equivalent 20\u002F400) in at least 1 eye\n\nExclusion Criteria:\n\n1. Previous or current diagnosis of any form of glaucoma (defined as cup-to-disc ratio \\> 0.7) or ocular hypertension (documented intraocular pressure (IOP) \\> 21 mm Hg without glaucomatous disc damage) requiring medical or surgical intervention\n2. History of steroid-induced IOP elevation \\> 25 mm Hg\n3. Presence of active proliferative diabetic retinopathy, defined as active neovascularization of disc (NVD), neovascularization elsewhere (NVE), neovascularization of iris (NVI), neovascularization of angle (NVA), or vitreous hemorrhage in the setting of active NVD or NVE",[59,60],"ADULT","OLDER_ADULT",[62],{"facility":63,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":72},"Retina Associates of Florida, LLC","Tampa","Florida","33609","United States",[69],{"name":70,"role":71},"Cindy Lopez","CONTACT",{"lat":73,"lon":74},27.94752,-82.45843,[76],{"name":77,"role":71,"phone":78,"email":79},"Freddie Batalla, MBA","919-443-5542","BETTIS-1@eclipselifesciences.com",[],[],[],{"nct_id":4,"conditions":84,"biomarkers":87},[85,86],"Diabetic Retinopathy","Macular edema due to diabetes mellitus",[],{"nct_id":4,"found":89,"summary":90,"prompt_version":100},true,{"design":91,"status":92,"heading":93,"summary":94,"follow_up":95,"word_count":96,"commitments":97,"compensation":98,"drugs_mentioned":99},"This is a randomized, masked Phase 2 study comparing three different treatments in about 75 participants.","completed","EC-104 Intravitreal Implant for Diabetic Macular Edema","This study is testing two doses of an investigational implant called EC-104 (high dose: fluocinolone acetonide 0.14 mg; low dose: fluocinolone acetonide 0.092 mg) against a currently available treatment, Ozurdex® (dexamethasone intravitreal implant 0.7 mg). The goal is to see how safe and effective these treatments are for people with diabetic macular edema (DME), a swelling in the eye caused by diabetes, who haven't responded well to other treatments. Researchers are looking for about 75 participants who are at least 18 years old. The main goal is to check for safety and how well the treatments work over 24 weeks. The study is currently recruiting, but the exact status is unclear.","Participants will be followed for ocular and systemic safety through Week 24.",111,"Not specified in the trial record.","Not stated in the trial record.",[39],"v2"]