The Effects of Intravitreal Ozurdex Implant in DME

NCT03475407 | Unknown Phase 4 DMC

• 1 other identifier: CRBF004
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edema; cytokine; dexamethasone

Outcome Measures

Primary Outcomes (1)

• Changes of Central foveal thickness(CFT, height in micrometers)

  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)

  Baseline, 6 weeks, 18 weeks

• Changes of Best corrected Visual acuity(BCVA, ETDRS scale)

  Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks

Study Arms (1)

Treatment Group

EXPERIMENTAL

Ozurdex intravitreal injection

Drug: Ozurdex intravitreal injection

Interventions

Ozurdex intravitreal injection DRUG

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

Treatment Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nune Eye Hospital, Seoul, Korea: lead

Study Sites (1)

Nune Eye Hospital

Seoul, 135-280, South Korea

RECRUITING

MeSH Terms

Interventions

Calcium Dobesilate

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Oh Woong Kwon, MD PhD

  Nune Eye Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oh Woong Kwon, MD, Ph D

CONTACT

+82+2+2086+7752; owkwon0301@yuhs.ac

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of retina center in Nune Eye Hospital

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: March 23, 2018
• Study Start: March 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

KR (1)