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| Name | Class |
|---|---|
| Allergan | INDUSTRY |
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A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravitreal dexamethasone implant | Experimental | Intravitreal dexamethasone 0.7mg implant (Ozurdex) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravitreal dexamethasone 0.7mg implant | Drug | Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata |
|
| Measure | Description | Time Frame |
|---|---|---|
| The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center) | after 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity | after 12 months | |
| The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography) | after 12 months |
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Inclusion Criteria:
Exclusion Criteria:
Those who have CSME without hard exudates
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)
Those who have a history of Intraocular surgery (e.g. cataract surgery) within 3 months
Those who have a visual acuity of contralateral eye less than 0.1 (10/100)
Those who received focal laser treatment on macula within 3 months
Those who had intravitreal anti-VEGF agent injection within 3 months
Those who had intravitreal triamcinolone injection within 6 months
Those who have other ophthalmologic disease affecting visual acuity (e.g. central corneal opacity, cataract change at lens center)
Those who have severe systemic disease (e.g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease)
Those who refuse to submit written consent
Those who cannot understand the contents of the clinical study and cooperate in the clinical trial
Those who are pregnant or lactating women
Those who have a history of vitrectomy
Those who require systemic corticosteroid or immunosuppressive agent treatment
Those who are banned from using Ozurdex
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hyun Woong Kim, M.D. | Contact | 82-51-890-8997 | maekbak@hanmail.net | |
| Chang Ki Yoon, M.D. | Contact | 82-51-890-8707 | syst18@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hyun Woong Kim, M.D. | Inje University | Study Director |
| Ji Eun Lee, M.D. | Pusan National University Hospital | Principal Investigator |
| Joo Eun Lee, M.D. |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gyeongsang National University Hospital | Recruiting | Jinju | Gyeongsangnam-do | 660-702 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19171208 | Background | 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. | |
| 7831044 | Background | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 13, 2020 | |
| Reset | Aug 27, 2020 |
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|
| The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography | after 12 months |
| The average change in number of microaneurysm in macula | after 12 months |
| The progression rate of cataract | for 12 months |
| Number of eyes having increased intraocular pressure | for 12 months |
| Inje University Haeundae Paik Hospital |
| Principal Investigator |
| Woo Jin Jeung, M.D. | Dong-A University Hospital | Principal Investigator |
| Sang Joon Lee, M.D. | Kosin University Gospel Hospital | Principal Investigator |
| In Young Chung, M.D. | Gyeongsang National University Hospital | Principal Investigator |
| Jae Pil Shin, M.D. | Kyungpook National University Hospital | Principal Investigator |
| Woo Hyok Chang, M.D. | Yeungnam University Hospital | Principal Investigator |
| Kosin University Gospel Hospital | Recruiting | Busan | 602-702 | South Korea |
|
| Dong-A University hospital | Recruiting | Busan | 602-715 | South Korea |
|
| Pusan national university hospital | Recruiting | Busan | 602-739 | South Korea |
|
| Inje University Haeundae Paik hospital | Recruiting | Busan | 612-030 | South Korea |
|
| Inje University Busan Paik hospital | Recruiting | Busan | 614-735 | South Korea |
|
| Kyungpook National University Hospital | Recruiting | Daegu | 700-721 | South Korea |
|
| Yeungnam University Medical Center | Recruiting | Daegu | 705-717 | South Korea |
|
| 8366922 | Background | 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. |
| 2866759 | Background | 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. |
| 20212197 | Background | 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. |
| 33451297 | Derived | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 13, 2020 | Aug 27, 2020 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D008269 | Macular Edema |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D008268 | Macular Degeneration |
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D004343 | Drug Implants |
| D002123 | Calcium Dobesilate |
| ID | Term |
|---|---|
| D003692 | Delayed-Action Preparations |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
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