{"id":"ozurdex-intravitreal-injection","safety":{"commonSideEffects":[{"rate":null,"effect":"Cataract progression"},{"rate":null,"effect":"Elevated intraocular pressure"},{"rate":null,"effect":"Conjunctival hemorrhage"},{"rate":null,"effect":"Vitreous hemorrhage"},{"rate":null,"effect":"Endophthalmitis"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"The implant releases dexamethasone, a potent corticosteroid, over several months directly into the eye. This local delivery suppresses inflammatory cytokines and reduces vascular permeability, thereby decreasing macular edema and improving vision in inflammatory retinal conditions. The sustained-release formulation allows for prolonged therapeutic effect with a single intravitreal injection.","oneSentence":"Ozurdex is a sustained-release dexamethasone implant that delivers corticosteroid directly into the vitreous to suppress inflammation and reduce macular edema.","_ai_confidence":"high"},"_scrapedAt":"2026-03-27T23:59:33.887Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Macular edema following retinal vein occlusion"},{"name":"Macular edema in uveitis"},{"name":"Diabetic macular edema"}]},"trialDetails":[{"nctId":"NCT04116398","phase":"PHASE2","title":"Pilot and Phase 2 Study of the Efficacy of a Treatment Protocol With Dexamethasone Implant Loading Dose in Patients With Diabetic Macular Edema (LOADEX)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hospices Civils de Lyon","startDate":"2020-11-30","conditions":"Diabetic Macular Edema","enrollment":53},{"nctId":"NCT06894017","phase":"","title":"Patient Preferences on Same-day Bilateral Intravitreal Dexamethasone Injections","status":"RECRUITING","sponsor":"Rigshospitalet, Denmark","startDate":"2025-01-13","conditions":"Informed Consent, Preference, Patient","enrollment":200},{"nctId":"NCT06951087","phase":"PHASE3","title":"Intravitreal and Intracameral DEX in NPDR","status":"ENROLLING_BY_INVITATION","sponsor":"Affiliated Hospital of Nantong University","startDate":"2022-01-31","conditions":"Non-Proliferative Diabetic Retinopathy","enrollment":80},{"nctId":"NCT06536491","phase":"PHASE1, PHASE2","title":"EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema","status":"RECRUITING","sponsor":"Eclipse Life Sciences, Inc.","startDate":"2024-08-19","conditions":"Diabetic Macular Edema","enrollment":75},{"nctId":"NCT05003258","phase":"NA","title":"Functional and Anatomical Outcomes of Dexamethasone Intra-vitreal Implant in Patients with Resistant Macular Edema Secondary to Retinal Vein Occlusion After Intravitreal Anti-VEGF Injection","status":"COMPLETED","sponsor":"Assiut University","startDate":"2021-10-07","conditions":"Macular Edema, Retinal Vein Occlusion","enrollment":25},{"nctId":"NCT04411693","phase":"PHASE4","title":"Comparative Study of Dexamethasone Implant to Intravitreal Aflibercept in Subjects With Diabetic Macular Edema","status":"COMPLETED","sponsor":"The Cleveland Clinic","startDate":"2020-04-10","conditions":"Diabetic Macular Edema","enrollment":23},{"nctId":"NCT03984110","phase":"PHASE4","title":"One Year Trial Evaluating Safety of Ozurdex With Eylea","status":"COMPLETED","sponsor":"Texas Retina Associates","startDate":"2019-06-11","conditions":"Diabetic Macular Edema","enrollment":50},{"nctId":"NCT02623426","phase":"PHASE3","title":"Macular Edema Ranibizumab v. Intravitreal Anti-inflammatory Therapy Trial","status":"COMPLETED","sponsor":"JHSPH Center for Clinical Trials","startDate":"2017-03-09","conditions":"Uveitis, Macular Edema","enrollment":194},{"nctId":"NCT04563299","phase":"PHASE4","title":"Effect on Pain and Inflammation With DEXTENZA Treatment in Patients Undergoing Intravitreal Anti-VEGF Injections","status":"TERMINATED","sponsor":"Retina Vitreous Associates of Florida","startDate":"2020-12-09","conditions":"Neovascular Age-related Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion","enrollment":10},{"nctId":"NCT02556424","phase":"PHASE3","title":"Efficacy and Tolerance Comparison Between Subconjunctival Injection of Triamcinolone and Intravitreal Implant of Dexamethasone for the Treatment of Inflammatory Macular Edema","status":"COMPLETED","sponsor":"Nantes University Hospital","startDate":"2016-01","conditions":"Inflammatory Macular Edema","enrollment":114},{"nctId":"NCT02688309","phase":"","title":"Pro-permeability and Pro-fibrosis Factors in the Aqueous of Patients With Retinal Diseases","status":"TERMINATED","sponsor":"Johns Hopkins University","startDate":"2015-01-13","conditions":"Macular Edema, Fibrosis of the Retina","enrollment":44},{"nctId":"NCT05372562","phase":"","title":"Risk Factors for the Recurrent Postoperative Macular Edema Treated With OZURDEX","status":"COMPLETED","sponsor":"Peking University","startDate":"2017-07-01","conditions":"Macular Edema","enrollment":30},{"nctId":"NCT05271539","phase":"PHASE3","title":"Intravitreal Ranibizumab Versus Its Combination With Dexamethasone in The Treatment of Diabetic Macular Edema","status":"COMPLETED","sponsor":"Cairo University","startDate":"2020-07-01","conditions":"Diabetic Macular Edema","enrollment":42},{"nctId":"NCT04856397","phase":"NA","title":"Ozurdex in Suboptimal Diabetic Macular Edema Patients","status":"UNKNOWN","sponsor":"Uptown Eye Specialists","startDate":"2021-05-25","conditions":"Diabetic Macular Edema","enrollment":200},{"nctId":"NCT04067856","phase":"NA","title":"Intravitreal Dexamethasone Implant (Ozurdex) Versus Bevacizumab in Patients With Diabetic Macular Edema Undergoing Cataract Surgery","status":"WITHDRAWN","sponsor":"Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center","startDate":"2020-01-01","conditions":"Diabetic Macular Edema, Cataract","enrollment":""},{"nctId":"NCT02121262","phase":"PHASE3","title":"A Safety and Efficacy Study of Dexamethasone Versus Laser Photocoagulation in Participants With Diabetic Macular Edema","status":"COMPLETED","sponsor":"Allergan","startDate":"2016-01-08","conditions":"Macular Edema","enrollment":284},{"nctId":"NCT04619303","phase":"PHASE4","title":"Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO","status":"COMPLETED","sponsor":"Lions Eye Institute, Perth, Western Australia","startDate":"2017-02-07","conditions":"Diabetic Macular Edema, Diabetic Retinopathy","enrollment":59},{"nctId":"NCT03889444","phase":"","title":"Chart Review: Drug Utilization Study in Participants Who Received Ozurdex™ (Dexamethasone Intravitreal Implant) 0.7 mg Injections for Visual Impairment Due to Diabetic Macular Edema (DME)","status":"COMPLETED","sponsor":"Allergan","startDate":"2019-01-15","conditions":"Diabetic Macular Edema","enrollment":141},{"nctId":"NCT04038125","phase":"PHASE4","title":"Increase in Capillary Plexus Density Level Following the Use of Ozurdex for the Treatment of DME","status":"UNKNOWN","sponsor":"Retina Macula Specialists of Miami, LLC","startDate":"2019-08-22","conditions":"Diabetic Macular Edema, Diabetic Retinopathy, Retinal Ischemia","enrollment":20},{"nctId":"NCT03971279","phase":"","title":"Dexamethasone Intravitreal Implant (Ozurdex®) for Recurrent Vogt-Koyanagi-Harada (VKH) Disease Posterior Uveitis","status":"COMPLETED","sponsor":"Benha University","startDate":"2017-01-01","conditions":"Posterior Uveitis","enrollment":16},{"nctId":"NCT03629210","phase":"PHASE2","title":"Combination OZURDEX® & EyLea® vs. OZURDEX® Monotherapy in IncompLete-Responders wIth Diabetic Macular Edema","status":"WITHDRAWN","sponsor":"Pradeepa Yoganathan","startDate":"2019-09","conditions":"Diabetic Macular Edema","enrollment":""},{"nctId":"NCT04089605","phase":"PHASE4","title":"Ranibizumab vs Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema","status":"COMPLETED","sponsor":"Far Eastern Memorial Hospital","startDate":"2017-06-01","conditions":"Diabetic Macular Edema","enrollment":48},{"nctId":"NCT01471054","phase":"PHASE2","title":"Dexamethasone Intravitreal Implant for Treatment of Macular Edema After Plaque Radiotherapy of Uveal Melanoma","status":"TERMINATED","sponsor":"Arman Mashayekhi","startDate":"2014-04","conditions":"Macular Edema, Cystoid Macular Edema, Uveal Melanoma","enrollment":6},{"nctId":"NCT03999125","phase":"PHASE4","title":"Anti-VEGF Therapy Versus Dexamethasone Implant for DME","status":"UNKNOWN","sponsor":"Sudhalkar Eye Hospital","startDate":"2019-06-25","conditions":"Clinically Significant Macular Edema Due to Diabetes Mellitus","enrollment":150},{"nctId":"NCT01427751","phase":"PHASE4","title":"Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion","status":"COMPLETED","sponsor":"Allergan","startDate":"2011-10-11","conditions":"Retinal Vein Occlusion, Macular Edema","enrollment":307},{"nctId":"NCT01492400","phase":"PHASE2","title":"Safety and Efficacy Study of Dexamethasone Versus Ranibizumab in Patients With Diabetic Macular Edema","status":"COMPLETED","sponsor":"Allergan","startDate":"2012-03-09","conditions":"Macular Edema","enrollment":363},{"nctId":"NCT01660802","phase":"PHASE3","title":"Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)","status":"COMPLETED","sponsor":"Allergan","startDate":"2012-09-04","conditions":"Macular Edema","enrollment":262},{"nctId":"NCT02471651","phase":"PHASE4","title":"Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema","status":"COMPLETED","sponsor":"California Retina Consultants","startDate":"2015-06","conditions":"Diabetic Macular Edema","enrollment":40},{"nctId":"NCT02374060","phase":"PHASE3","title":"PeriOcular and INTravitreal Corticosteroids for Uveitic Macular Edema Trial","status":"COMPLETED","sponsor":"JHSPH Center for Clinical Trials","startDate":"2015-06-16","conditions":"Macular Edema, Uveitis","enrollment":192},{"nctId":"NCT02995746","phase":"NA","title":"Intravitreal Dexamethasone Implant for Persistent Macular Thickening and Edema After Vitrectomy for Epiretinal Membrane","status":"TERMINATED","sponsor":"Wills Eye","startDate":"2016-01-28","conditions":"Macular Edema, Epiretinal Membrane, Vitrectomy","enrollment":3},{"nctId":"NCT01945866","phase":"PHASE2","title":"Phase II Combination Steroid and Anti-VEGF for Persistent DME","status":"COMPLETED","sponsor":"Jaeb Center for Health Research","startDate":"2014-02","conditions":"Diabetic Macular Edema","enrollment":129},{"nctId":"NCT02684084","phase":"PHASE4","title":"Combination OZURDEX® & LUCENTIS® vs. OZURDEX® Monotherapy in Incomplete-Responders With Diabetic Macular Edema","status":"TERMINATED","sponsor":"North Toronto Eye Care Laser and Eye Specialists","startDate":"2015-11","conditions":"Diabetic Macular Edema","enrollment":5},{"nctId":"NCT02121197","phase":"","title":"Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.","status":"COMPLETED","sponsor":"Association for Innovation and Biomedical Research on Light and Image","startDate":"2014-08","conditions":"Diabetic Macular Edema","enrollment":321},{"nctId":"NCT01243086","phase":"PHASE2","title":"OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab","status":"COMPLETED","sponsor":"McMaster University","startDate":"2011-03","conditions":"Wet Macular Degeneration","enrollment":10},{"nctId":"NCT01231633","phase":"NA","title":"Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)","status":"COMPLETED","sponsor":"Long Island Vitreoretinal Consultants","startDate":"2010-09","conditions":"Macular Edema, Central Retinal Vein Occlusion","enrollment":27},{"nctId":"NCT03475407","phase":"PHASE4","title":"The Effects of Intravitreal Ozurdex Implant in DME","status":"UNKNOWN","sponsor":"Nune Eye Hospital, Seoul, Korea","startDate":"2015-03","conditions":"Diabetic Macular Edema","enrollment":20},{"nctId":"NCT01946399","phase":"NA","title":"Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF","status":"TERMINATED","sponsor":"Retina Research Institute, LLC","startDate":"2013-09","conditions":"Retinal Vein Occlusion (RVO), Macular Edema","enrollment":10},{"nctId":"NCT01449682","phase":"PHASE3","title":"Efficacy of an Intravitreal DEX Implant in Retinal Vein Occlusion Following Treatment With Anti-VEGF Injections.","status":"COMPLETED","sponsor":"Retina Macula Institute","startDate":"2011-10","conditions":"Retinal Vein Occlusion, Macular Edema","enrollment":10},{"nctId":"NCT02804360","phase":"PHASE2","title":"Intravitreal Dexamethasone Implant in Retinitis Pigmentosa-related Macular Edema- a Retrospective Study","status":"UNKNOWN","sponsor":"Rafic Hariri University Hospital","startDate":"2015-01","conditions":"Retinitis Pigmentosa, Cystoid Macular Edema","enrollment":50},{"nctId":"NCT01580020","phase":"PHASE4","title":"Extension Study to Compare Long-term Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With RVO","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2012-05","conditions":"Retinal Vein Occlusion","enrollment":175},{"nctId":"NCT01827722","phase":"PHASE4","title":"Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein Occlusion","status":"UNKNOWN","sponsor":"Valley Retina Institute","startDate":"2013-05","conditions":"Macular Edema, Central Retinal Vein Occlusion","enrollment":45},{"nctId":"NCT01748487","phase":"PHASE3","title":"The Effect of Intravitreal Ozurdex on DME After Cataract Surgery","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2012-12","conditions":"Diabetic Macular Edema","enrollment":24},{"nctId":"NCT02036424","phase":"PHASE4","title":"Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema","status":"COMPLETED","sponsor":"Raj K. Maturi, MD","startDate":"2014-01","conditions":"Diabetic Macular Edema","enrollment":45},{"nctId":"NCT01298076","phase":"PHASE2","title":"Intravitreal Bevacizumab (Avastin®) Versus Intravitreal Dexamethasone (Ozurdex™) for Persistent Diabetic Macular Oedema","status":"COMPLETED","sponsor":"University of Sydney","startDate":"2010-10","conditions":"Diabetic Retinopathy, Macular Edema","enrollment":61},{"nctId":"NCT02399657","phase":"PHASE4","title":"Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema","status":"UNKNOWN","sponsor":"Inje University","startDate":"2015-02","conditions":"Diabetes Mellitus, Macular Edema, Retinal Exudates and Deposits","enrollment":48},{"nctId":"NCT01870440","phase":"PHASE4","title":"TAHOE: Intravitreal Dexamethasone Implant (Ozurdex) for Uveitic Macular Edema","status":"COMPLETED","sponsor":"Northern California Retina Vitreous Associates","startDate":"2013-05","conditions":"Macular Edema, Uveitis","enrollment":10},{"nctId":"NCT01581151","phase":"NA","title":"Ozurdex With Rescue Lucentis for Treating Macular Edema Secondary to Retinal Vein Occlusion","status":"UNKNOWN","sponsor":"Brian Burke, MPH","startDate":"2011-09","conditions":"Retinal Vein Occlusion","enrollment":30},{"nctId":"NCT01396057","phase":"PHASE3","title":"Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO)","status":"COMPLETED","sponsor":"Novartis Pharmaceuticals","startDate":"2011-07","conditions":"Visual Impairment, Macular Edema, Branch Retinal Vein Occlusion","enrollment":244},{"nctId":"NCT01546402","phase":"PHASE4","title":"Intraoperative Dexamethasone Implant Improves Outcome of Cataract Surgery With Diabetic Macular Edema","status":"COMPLETED","sponsor":"Post Graduate Institute of Medical Education and Research, Chandigarh","startDate":"2011-05","conditions":"Macular Edema, Cystoid, Vision Disorders, Diabetic Macular Edema","enrollment":20},{"nctId":"NCT01027650","phase":"PHASE1, PHASE2","title":"Safety and Efficacy of AGN208397 in the Treatment of Macular Edema Associated With Retinal Vein Occlusion (RVO)","status":"COMPLETED","sponsor":"Allergan","startDate":"2010-03","conditions":"Macular Edema, Retinal Vein Occlusion","enrollment":121},{"nctId":"NCT01566526","phase":"","title":"Retrospective Data Collection Study in Patients Receiving Two or More OZURDEX® Injections for Macular Oedema Secondary to Retinal Vein Occlusion","status":"COMPLETED","sponsor":"Allergan","startDate":"2012-03","conditions":"Retinal Vein Occlusion, Macular Oedema","enrollment":26},{"nctId":"NCT01411696","phase":"","title":"Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)","status":"COMPLETED","sponsor":"Allergan","startDate":"2011-07","conditions":"Retinal Vein Occlusion, Macular Edema","enrollment":289},{"nctId":"NCT01445626","phase":"","title":"A Retrospective Data Collection Study in Patients Receiving Dexamethasone Intravitreal Implant (Ozurdex®) for Macular Oedema Due to Retinal Vein Occlusion (RVO)","status":"COMPLETED","sponsor":"Allergan","startDate":"2011-10","conditions":"Macular Edema","enrollment":87},{"nctId":"NCT01122511","phase":"PHASE2","title":"Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration","status":"TERMINATED","sponsor":"Allergan","startDate":"2010-08","conditions":"Subfoveal Choroidal Neovascularization, Age-Related Maculopathy","enrollment":4},{"nctId":"NCT01030601","phase":"PHASE2","title":"Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS)","status":"COMPLETED","sponsor":"University Health Network, Toronto","startDate":"2010-01","conditions":"Diabetes, Macular Edema, Pseudophakia","enrollment":48}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":4,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":[],"phase":"marketed","status":"active","brandName":"Ozurdex intravitreal injection","genericName":"Ozurdex intravitreal injection","companyName":"Nune Eye Hospital, Seoul, Korea","companyId":"nune-eye-hospital-seoul-korea","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Ozurdex is a sustained-release dexamethasone implant that delivers corticosteroid directly into the vitreous to suppress inflammation and reduce macular edema. Used for Macular edema following retinal vein occlusion, Macular edema in uveitis, Diabetic macular edema.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}