Clinical trial NCT02399657: Effect of Dexamethasone Implant in Hard Exudate Complicated With Diabetic Macular Edema
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diabetes Mellitus
Macular Edema
Retinal Exudates and Deposits
Keywords: diabetes mellitus
macular edema
hard exudate
intravitreal injections
dexamethasone
implant
Lead sponsor: Inje University
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2015-03-26
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)
timeFrame: after 12 months
Secondary outcomes:
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
Other outcomes:
Locations:
city: Jinju
country: Korea, Republic of
facility: Gyeongsang National University Hospital
state: Gyeongsangnam-do
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Dong-A University hospital
city: Busan
country: Korea, Republic of
facility: Pusan national university hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik hospital
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
Study officials:
affiliation: Inje University
name: Hyun Woong Kim, M.D.
role: STUDY_DIRECTOR
affiliation: Pusan National University Hospital
name: Ji Eun Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Inje University Haeundae Paik Hospital
name: Joo Eun Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Dong-A University Hospital
name: Woo Jin Jeung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kosin University Gospel Hospital
name: Sang Joon Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Gyeongsang National University Hospital
name: In Young Chung, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Kyungpook National University Hospital
name: Jae Pil Shin, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yeungnam University Hospital
name: Woo Hyok Chang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.