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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02399657
• Other study ID #: EXTINCT
• Status: Recruiting
• Phase: Phase 4
• First received: March 18, 2015
• Last updated: April 2, 2015
• Start date: February 2015
• Est. completion date: December 2016

Study information

• Verified date: April 2015
• Source: Inje University
• Contact: Hyun Woong Kim, M.D.
• Phone: 82-51-890-8997
• Email: maekbak[@]hanmail.net
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Edema
• Macular Edema
• Retinal Exudates and Deposits

Intervention

Drug:
• Intravitreal dexamethasone 0.7mg implant
Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University hospital	Busan
Korea, Republic of	Inje University Busan Paik hospital	Busan
Korea, Republic of	Inje University Haeundae Paik hospital	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan national university hospital	Busan
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam University Medical Center	Daegu
Korea, Republic of	Gyeongsang National University Hospital	Jinju	Gyeongsangnam-do

Sponsors (2)

Lead Sponsor	Collaborator
Inje University	Allergan

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)		after 12 months	No
Secondary	The average change in ETDRS (Early Treatment Diabetic Retinopathy Study) visual acuity		after 12 months	No
Secondary	The Ratio of eyes with central macular thickness under 290 micrometer in OCT (optical coherence tomography)		after 12 months	No
Secondary	The Ratio of eyes showing reduced perifoveal capillary leakage in fluorescein angiography		after 12 months	No
Secondary	The average change in number of microaneurysm in macula		after 12 months	No
Secondary	The progression rate of cataract		for 12 months	Yes
Secondary	Number of eyes having increased intraocular pressure		for 12 months	Yes