Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 10:43 AM
Study NCT ID:
NCT02399657
Status:
UNKNOWN
Last Update Posted:
2015-04-06
First Post:
2015-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-08-27', 'releaseDate': '2020-08-13'}], 'estimatedResultsFirstSubmitDate': '2020-08-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004343', 'term': 'Drug Implants'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D003692', 'term': 'Delayed-Action Preparations'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-04-02', 'studyFirstSubmitDate': '2015-03-18', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2015-04-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)', 'timeFrame': 'after 12 months'}], 'secondaryOutcomes': [{'measure': 'The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity', 'timeFrame': 'after 12 months'}, {'measure': 'The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)', 'timeFrame': 'after 12 months'}, {'measure': 'The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography', 'timeFrame': 'after 12 months'}, {'measure': 'The average change in number of microaneurysm in macula', 'timeFrame': 'after 12 months'}, {'measure': 'The progression rate of cataract', 'timeFrame': 'for 12 months'}, {'measure': 'Number of eyes having increased intraocular pressure', 'timeFrame': 'for 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'macular edema', 'hard exudate', 'intravitreal injections', 'dexamethasone', 'implant'], 'conditions': ['Diabetes Mellitus', 'Macular Edema', 'Retinal Exudates and Deposits']}, 'referencesModule': {'references': [{'pmid': '19171208', 'type': 'BACKGROUND', 'citation': 'Bhagat N, Grigorian RA, Tutela A, Zarbin MA. Diabetic macular edema: pathogenesis and treatment. Surv Ophthalmol. 2009 Jan-Feb;54(1):1-32. doi: 10.1016/j.survophthal.2008.10.001.'}, {'pmid': '7831044', 'type': 'BACKGROUND', 'citation': 'Klein R, Klein BE, Moss SE, Cruickshanks KJ. The Wisconsin Epidemiologic Study of Diabetic Retinopathy. XV. The long-term incidence of macular edema. Ophthalmology. 1995 Jan;102(1):7-16. doi: 10.1016/s0161-6420(95)31052-4.'}, {'pmid': '8366922', 'type': 'BACKGROUND', 'citation': 'Diabetes Control and Complications Trial Research Group; Nathan DM, Genuth S, Lachin J, Cleary P, Crofford O, Davis M, Rand L, Siebert C. The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. N Engl J Med. 1993 Sep 30;329(14):977-86. doi: 10.1056/NEJM199309303291401.'}, {'pmid': '2866759', 'type': 'BACKGROUND', 'citation': 'Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.'}, {'pmid': '20212197', 'type': 'BACKGROUND', 'citation': 'Haller JA, Kuppermann BD, Blumenkranz MS, Williams GA, Weinberg DV, Chou C, Whitcup SM; Dexamethasone DDS Phase II Study Group. Randomized controlled trial of an intravitreous dexamethasone drug delivery system in patients with diabetic macular edema. Arch Ophthalmol. 2010 Mar;128(3):289-96. doi: 10.1001/archophthalmol.2010.21.'}, {'pmid': '33451297', 'type': 'DERIVED', 'citation': 'Yoon CK, Sagong M, Shin JP, Lee SJ, Lee JE, Lee JE, Chung I, Jeong WJ, Pak KY, Kim HW. Title: efficacy of intravitreal dexamethasone implant on hard exudate in diabetic macular edema. BMC Ophthalmol. 2021 Jan 15;21(1):41. doi: 10.1186/s12886-020-01786-2.'}]}, 'descriptionModule': {'briefSummary': 'A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.', 'detailedDescription': 'Diabetic macular edema (DME) is important vision threatening complication of diabetes mellitus. Laser photocoagulation, vitrectomy, intravitreal steroid injection and intravitreal antiVEGF (anti vascular endothelial growth factor) injection are being used as treatment of DME. Sustained releasing intravitreal dexamethasone implant has been known to be effective in reducing the central retinal thickness and gain of vision for DME. Although hard exudate at macula is important pathology of DME, impact of intravitreal dexamethasone implant on hard exudate are not studied yet. Therefore the investigators designed the descriptive study to reveal the hard exudate change in DME eyes treated with intravitreal dexamethasone implant.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center\n2. Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)\n3. Those who have a central macular thickness on OCT over 300 micrometer\n4. If both eyes are eligible, eye having more hard exudates is selected (contralateral eye should be treated with corticosteroid other than Ozurdex or focal laser photocoagulation, anti-VEGF (vascular endothelial growth factor) injection is not allowed in contralateral eye)\n\nExclusion Criteria:\n\n1. Those who have CSME without hard exudates\n2. Those who have macular edema not related with diabetic retinopathy (e.g. AMD (age-related macular degeneration), uveitis, retinal vein occlusion and untreated malignant hypertension)\n3. Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months\n4. Those who have a visual acuity of contralateral eye less than 0.1 (10/100)\n5. Those who received focal laser treatment on macula within 3 months\n6. Those who had intravitreal anti-VEGF agent injection within 3 months\n7. Those who had intravitreal triamcinolone injection within 6 months\n8. Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)\n9. Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)\n10. Those who refuse to submit written consent\n11. Those who cannot understand the contents of the clinical study and cooperate in the clinical trial\n12. Those who are pregnant or lactating women\n13. Those who have a history of vitrectomy\n14. Those who require systemic corticosteroid or immunosuppressive agent treatment\n15. Those who are banned from using Ozurdex\n\n * Ocular infection or periocular infection\n * Advanced glaucoma\n * Hypersensitivity to dexamethasone or other component of Ozurdex\n * Posterior lens capsule rupture or Aphakia\n * Anterior chamber intraocular lens or posterior capsule rupture'}, 'identificationModule': {'nctId': 'NCT02399657', 'briefTitle': 'Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'EXTINCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intravitreal dexamethasone implant', 'description': 'Intravitreal dexamethasone 0.7mg implant (Ozurdex)', 'interventionNames': ['Drug: Intravitreal dexamethasone 0.7mg implant']}], 'interventions': [{'name': 'Intravitreal dexamethasone 0.7mg implant', 'type': 'DRUG', 'otherNames': ['Ozurdex injection'], 'description': 'Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata', 'armGroupLabels': ['Intravitreal dexamethasone implant']}]}, 'contactsLocationsModule': {'locations': [{'zip': '660-702', 'city': 'Jinju', 'state': 'Gyeongsangnam-do', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'In Young Chung, M.D.', 'role': 'CONTACT'}], 'facility': 'Gyeongsang National University Hospital', 'geoPoint': {'lat': 35.19278, 'lon': 128.08472}}, {'zip': '602-702', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang Joon Lee, M.D.', 'role': 'CONTACT'}], 'facility': 'Kosin University Gospel Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-715', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Jin Jeung, M.D.', 'role': 'CONTACT'}], 'facility': 'Dong-A University hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '602-739', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Ji Eun Lee, M.D.', 'role': 'CONTACT'}], 'facility': 'Pusan national university hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '612-030', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Joo Eun Lee, M.D.', 'role': 'CONTACT'}], 'facility': 'Inje University Haeundae Paik hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '614-735', 'city': 'Busan', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Hyun Woong Kim, M.D.', 'role': 'CONTACT'}], 'facility': 'Inje University Busan Paik hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}, {'zip': '700-721', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae Pil Shin, M.D.', 'role': 'CONTACT'}], 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}, {'zip': '705-717', 'city': 'Daegu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Woo Hyok Chang, M.D.', 'role': 'CONTACT'}], 'facility': 'Yeungnam University Medical Center', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'centralContacts': [{'name': 'Hyun Woong Kim, M.D.', 'role': 'CONTACT', 'email': 'maekbak@hanmail.net', 'phone': '82-51-890-8997'}, {'name': 'Chang Ki Yoon, M.D.', 'role': 'CONTACT', 'email': 'syst18@gmail.com', 'phone': '82-51-890-8707'}], 'overallOfficials': [{'name': 'Hyun Woong Kim, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Inje University'}, {'name': 'Ji Eun Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pusan National University Hospital'}, {'name': 'Joo Eun Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University Haeundae Paik Hospital'}, {'name': 'Woo Jin Jeung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dong-A University Hospital'}, {'name': 'Sang Joon Lee, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kosin University Gospel Hospital'}, {'name': 'In Young Chung, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gyeongsang National University Hospital'}, {'name': 'Jae Pil Shin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}, {'name': 'Woo Hyok Chang, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Yeungnam University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Hyun Woong Kim', 'investigatorAffiliation': 'Inje University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-08-13', 'type': 'RELEASE'}, {'date': '2020-08-27', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Hyun Woong Kim, Associate professor, Inje University'}}}}