The Effects of Intravitreal Ozurdex Implant in DME

Diabetic Macular Edema Clinical Trial

Official title:

The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03475407
• Other study ID #: CRBF004
• Status: Recruiting
• Phase: Phase 4
• First received: April 14, 2015
• Last updated: March 22, 2018
• Start date: March 2015
• Est. completion date: December 2018

Study information

• Verified date: March 2018
• Source: Nune Eye Hospital, Seoul, Korea
• Contact: Oh Woong Kwon, MD, Ph D
• Phone: +82+2+2086+7752
• Email: owkwon0301[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Ozurdex intravitreal injection
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

Locations

Country	Name	City	State
Korea, Republic of	Nune Eye Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Nune Eye Hospital, Seoul, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Central foveal thickness(CFT, height in micrometers)		Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks
Secondary	Changes of aqueous humor cytokine (VFGF, IL-2, IL-6,IL-8, MCP-1)		Baseline, 6 weeks, 18 weeks
Secondary	Changes of Best corrected Visual acuity(BCVA, ETDRS scale)		Baseline, 1 week, 6 weeks, 12 weeks, 18 weeks, 24 weeks