Diabetic Macular EdemaPhase 4NCT03475407
The Effects of Intravitreal Ozurdex Implant in DME
A Phase 4 study testing Ozurdex intravitreal injection in people with Diabetic Macular Edema, run by Nune Eye Hospital, Seoul, Korea at 1 site in South Korea.
Trial summary
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Ozurdex intravitreal injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2015to Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
- Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
- Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
- Diabetic patients with cystoids macular edema
- Minimum central thickness on OCT not less than 300 microns
- BCVA 20/30~20/320
Who cannot join
- Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
- Patients with history of ocular hypertension or glaucoma
- Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
- Patients with macular ischemia on FFA
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
- Patients whose posterior lens capsule is not intact.
Show all 10Show fewer
- patients with known hypersensitivity to any components of this product.
- patients with vitreous hemorrhage
- patients who have systemic treatment effect on study results
- patients who enrolled other clinical study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Nune Eye Hospital
Seoul, 135-280
Jin Hae Lee, MD, +82-10-2765-5303, seastar01@hanmail.net
Oh Woong Kwon, MD, Ph D
About this study
Official title: The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.
- Conditions
- Diabetic Macular Edema
- Being tested
- Ozurdex intravitreal injection
- Keywords
- Diabetic macular edema, cytokine, dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ozurdex intravitreal injectionDrug
- Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline
- AC paracentesis at 6 wk
- intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Ozurdex intravitreal injection Receives: Drug: Ozurdex intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Central foveal thickness(CFT, height in micrometers)
Measured: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary outcomes (2)
Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)
Measured: Baseline, 6 weeks, 18 weeks
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)
Measured: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study startMar 2015
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nune Eye Hospital, Seoul, Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oh Woong Kwon, Nune Eye Hospital, Seoul, Korea
- Investigators
- Oh Woong Kwon, MD PhD, Principal investigator, Nune Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03475407
- Sponsor's protocol ID
- CRBF004
- Status last verified
- Mar 2018
- First submitted
- 14 Apr 2015
- Last updated
- 23 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
- ClinicalTrials.gov ID
- NCT03475407
- Acronym / sponsor ID
- CRBF004
- Conditions
- Diabetic Macular Edema
- Keywords
- Diabetic macular edema, cytokine, dexamethasone
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Nune Eye Hospital, Seoul, KoreaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Intravitreal Ozurdex implant therapy improves visual outcome and OCT findings. The purpose of this study is that these results are correlated with the change of cytokine level known to be increased in DME patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Ozurdex intravitreal injectionOzurdex intravitreal injection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- The patients of Type 1 or Type 2 Diabetes Mellitus fulfilling the following inclusion criteria shall be enrolled in the study:
- Patients of Non Proliferative Diabetic Retinopathy(NPDR) with clinically significant macular edema(CSME)
- Patients with Proliferative Diabetic Retinopathy(PDR) with CSME where proliferative component has been adequately treated with laser photocoagulation
- Diabetic patients with cystoids macular edema
- Minimum central thickness on OCT not less than 300 microns
Key exclusion criteria (10 listed)
- Patients with history of Anti-VEGF or steroid injection, any type of laser treatments, vitrectomy, cataract surgery within 6 months
- Patients with history of ocular hypertension or glaucoma
- Patients with media haze or pupillary non-dilation that does not allow good fundus photography, FFA and OCT
- Patients with macular ischemia on FFA
- Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ozurdex intravitreal injection1. Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline 2. AC paracentesis at 6 wk 3. intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk | Drug | Treatment Group |
Primary outcome
Changes of Central foveal thickness(CFT, height in micrometers)
Time frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
2 secondary outcomes
Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)
Time frame: Baseline, 6 weeks, 18 weeks
Changes of Best corrected Visual acuity(BCVA, ETDRS scale)
Time frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Woong Kwon, MD PhD principal investigator
Nune Eye Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ozurdex intravitreal injection in people with Diabetic Macular Edema, run by Nune Eye Hospital, Seoul, Korea at 1 site 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 6 inclusion and 10 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 23 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Oh Woong Kwon, MD, Ph D (+82+2+2086+7752, owkwon0301@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Central foveal thickness(CFT, height in micrometers) (time frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.