Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effects of Intravitreal Ozurdex Implant in DME

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475407
Recruitment Status : Unknown
Verified March 2018 by Oh Woong Kwon, Nune Eye Hospital, Seoul, Korea.
Recruitment status was:  Recruiting
First Posted : March 23, 2018
Last Update Posted : March 23, 2018
Sponsor:
Information provided by (Responsible Party):
Oh Woong Kwon, Nune Eye Hospital, Seoul, Korea

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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.

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Ozurdex intravitreal injection Phase 4

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor
Actual Study Start Date : March 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Treatment Group
Ozurdex intravitreal injection
 Drug: Ozurdex intravitreal injection
  1. 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Changes of Central foveal thickness(CFT, height in micrometers) [ Time Frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks ]

Secondary Outcome Measures :
  1. Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1) [ Time Frame: Baseline, 6 weeks, 18 weeks ]
  2. Changes of Best corrected Visual acuity(BCVA, ETDRS scale) [ Time Frame: Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.
  • 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475407


Contacts
Layout table for location contacts
Contact: Oh Woong Kwon, MD, Ph D +82+2+2086+7752 owkwon0301@yuhs.ac

Locations
Layout table for location information
Korea, Republic of
Nune Eye Hospital Recruiting
Seoul, Korea, Republic of, 135-280
Contact: Jin Hae Lee, MD    +82-10-2765-5303    seastar01@hanmail.net   
Principal Investigator: Oh Woong Kwon, MD, Ph D         
Sub-Investigator: Jin Hae Lee, MD         
Sponsors and Collaborators
Nune Eye Hospital, Seoul, Korea
Investigators
Layout table for investigator information
Principal Investigator: Oh Woong Kwon, MD PhD Nune Eye Hospital
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Oh Woong Kwon, Chief of retina center in Nune Eye Hospital, Nune Eye Hospital, Seoul, Korea
ClinicalTrials.gov Identifier: NCT03475407    
Other Study ID Numbers: CRBF004
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: March 23, 2018
Last Verified: March 2018
Keywords provided by Oh Woong Kwon, Nune Eye Hospital, Seoul, Korea:
Diabetic macular edema
cytokine
dexamethasone
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Dexamethasone
Dexamethasone acetate
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action