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Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema

Information source: Inje University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus; Macular Edema; Retinal Exudates and Deposits

Intervention: Intravitreal dexamethasone 0.7mg implant (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Inje University

Official(s) and/or principal investigator(s):
Hyun Woong Kim, M.D., Study Director, Affiliation: Inje University
Ji Eun Lee, M.D., Principal Investigator, Affiliation: Pusan National University Hospital
Joo Eun Lee, M.D., Principal Investigator, Affiliation: Inje University
Woo Jin Jeung, M.D., Principal Investigator, Affiliation: Dong-A University Hospital
Sang Joon Lee, M.D., Principal Investigator, Affiliation: Kosin University Gospel Hospital
In Young Chung, M.D., Principal Investigator, Affiliation: Gyeongsang National University Hospital
Jae Pil Shin, M.D., Principal Investigator, Affiliation: Kyungpook National University
Woo Hyok Chang, M.D., Principal Investigator, Affiliation: Yeungnam University

Overall contact:
Hyun Woong Kim, M.D., Phone: 82-51-890-8997, Email: maekbak@hanmail.net

Summary

A Single Arm, Single Dose Study to Evaluate the Effect of intravitreal dexamethasone implant (Ozurdex®) on hard exudates of diabetic macular edema.

Clinical Details

Official title: A Single Arm, Single Dose Study to Evaluate the Effect of Intravitreal Dexamethasone Implant (Ozurdex®) on Hard Exudates of Diabetic Macular Edema

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)

Secondary outcome:

The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity

The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)

The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography

The average change in number of microaneurysm in macula

The progression rate of cataract

Number of eyes having increased intraocular pressure

Detailed description: 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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center 2. Those who have a BCVA (best corrected visual acuity) of study eye between 0. 06(20/320) and 0. 5(20/40) 3. Those who have a central macular thickness on OCT over 300 micrometer 4. 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) Exclusion Criteria: 1. Those who have CSME without hard exudates 2. 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) 3. Those who have a history of Intraocular surgery (e. g. cataract surgery) within 3 months 4. Those who have a visual acuity of contralateral eye less than 0. 1 (10/100) 5. Those who received focal laser treatment on macula within 3 months 6. Those who had intravitreal anti-VEGF agent injection within 3 months 7. Those who had intravitreal triamcinolone injection within 6 months 8. Those who have other ophthalmologic disease affecting visual acuity (e. g. central corneal opacity, cataract change at lens center) 9. Those who have severe systemic disease (e. g. uncontrolled DM, hypertension, cardiovascular disease, cerebrovascular disease) 10. Those who refuse to submit written consent 11. Those who cannot understand the contents of the clinical study and cooperate in the clinical trial 12. Those who are pregnant or lactating women 13. Those who have a history of vitrectomy 14. Those who require systemic corticosteroid or immunosuppressive agent treatment 15. Those who are banned from using Ozurdex

- Ocular infection or periocular infection

- Advanced glaucoma

- Hypersensitivity to dexamethasone or other component of Ozurdex

- Posterior lens capsule rupture or Aphakia

- Anterior chamber intraocular lens or posterior capsule rupture

Locations and Contacts

Hyun Woong Kim, M.D., Phone: 82-51-890-8997, Email: maekbak@hanmail.net

Dong-A University hospital, Busan 602-715, Korea, Republic of; Recruiting
Woo Jin Jeung, M.D.

Inje University Busan Paik hospital, Busan 614-735, Korea, Republic of; Recruiting
Hyun Woong Kim, M.D.

Inje University Haeundae Paik hospital, Busan 612-030, Korea, Republic of; Recruiting
Joo Eun Lee, M.D.

Kosin University Gospel Hospital, Busan 602-702, Korea, Republic of; Recruiting
Sang Joon Lee, M.D.

Pusan national university hospital, Busan 602-739, Korea, Republic of; Recruiting
Ji Eun Lee, M.D.

Kyungpook National University Hospital, Daegu 700-721, Korea, Republic of; Recruiting
Jae Pil Shin, M.D.

Yeungnam University Medical Center, Daegu 705-717, Korea, Republic of; Recruiting
Woo Hyok Chang, M.D.

Gyeongsang National University Hospital, Jinju, Gyeongsangnam-do 660-702, Korea, Republic of; Recruiting
In Young Chung, M.D.

Additional Information

Related publications:

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. Review.

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.

The effect of intensive treatment of diabetes on the development and progression of long-term complications in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial Research Group. N Engl J Med. 1993 Sep 30;329(14):977-86.

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.

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.

Starting date: February 2015
Last updated: April 2, 2015

Page last updated: August 23, 2015

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