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Diabetes MellitusPhase 4NCT02399657

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

A Phase 4 study testing Intravitreal dexamethasone 0.7mg implant in people with Diabetes Mellitus and Macular Edema, run by Inje University at 8 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 20 to 80 years
What is being tested?
Intravitreal dexamethasone 0.7mg implant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
8 sitesSouth Korea
Study dates
Feb 2015to Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients diagnosed with CSME (clinically significant macular edema) with hard exudates within 1500 micrometer from foveal center
  • Those who have a BCVA (best corrected visual acuity) of study eye between 0.06(20/320) and 0.5(20/40)
  • Those who have a central macular thickness on OCT over 300 micrometer
  • 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)

Who cannot join

  • 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
Show all 20Show fewer
  • 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
  • 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

Trial locations and contacts

8 sites in 1 country.

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

8 sites in 1 country

South Korea8 sites, 8 recruiting

  • Kosin University Gospel Hospital

    Busan, 602-702

    Sang Joon Lee, M.D.

    Recruiting

  • Dong-A University hospital

    Busan, 602-715

    Woo Jin Jeung, M.D.

    Recruiting

  • Pusan national university hospital

    Busan, 602-739

    Ji Eun Lee, M.D.

    Recruiting

  • Inje University Haeundae Paik hospital

    Busan, 612-030

    Joo Eun Lee, M.D.

    Recruiting

  • Inje University Busan Paik hospital

    Busan, 614-735

    Hyun Woong Kim, M.D.

    Recruiting

  • Kyungpook National University Hospital

    Daegu, 700-721

    Jae Pil Shin, M.D.

    Recruiting

  • Yeungnam University Medical Center

    Daegu, 705-717

    Woo Hyok Chang, M.D.

    Recruiting

  • Gyeongsang National University Hospital

    Jinju, Gyeongsangnam-do, 660-702

    In Young Chung, M.D.

    Recruiting

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Intravitreal dexamethasone 0.7mg implant
Keywords
diabetes mellitus, macular edema, hard exudate, intravitreal injections, dexamethasone, implant
Medical subject headings
Diabetes Mellitus, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intravitreal dexamethasone 0.7mg implantDrug

    Also called Ozurdex injection

    Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata

Study groups in NCT02399657
Study groupRoleWhat they receive
Intravitreal dexamethasone implantExperimentalIntravitreal dexamethasone 0.7mg implant (Ozurdex)
Receives: Drug: Intravitreal dexamethasone 0.7mg implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center)

    Measured: after 12 months

Secondary outcomes (6)

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

    Measured: after 12 months

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

    Measured: after 12 months

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

    Measured: after 12 months

  4. The average change in number of microaneurysm in macula

    Measured: after 12 months

  5. The progression rate of cataract

    Measured: for 12 months

  6. Number of eyes having increased intraocular pressure

    Measured: for 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Mar 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02399657
Sponsor's protocol ID
EXTINCT
Status last verified
Apr 2015
First submitted
18 Mar 2015
Last updated
6 Apr 2015
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 19171208

  • 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.

    PubMed 7831044

  • 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.

    PubMed 8366922

  • 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.

    PubMed 2866759

  • 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.

    PubMed 20212197

  • 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.

    PubMed 33451297

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Intravitreal dexamethasone 0.7mg implant in people with Diabetes Mellitus and Macular Edema, run by Inje University at 8 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Hyun Woong Kim, M.D. (82-51-890-8997, maekbak@hanmail.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The ratio of eyes showing reduced hard exudates in macula (1500 micrometer from foveal center) (time frame: after 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02399657, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2015.

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