Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema

NCT ID: NCT04448496

Last Updated: 2020-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-22
• Study Completion Date: 2021-12-31

Brief Summary

The purpose of the investigator's study is to evaluate the efficacy and safety profile of the pro re nata (PRN) regimen to 12 months by using intravitreal dexamethasone implant in eyes with treatment-naive diabetic macular edema patients.

Detailed Description

Pathogenesis of diabetic macular edema (DME) involves inflammation, angiogenesis, and oxidative stress processes provoked mainly by cytokines such as interleukin (IL)-6, 8, and monocyte chemotactic protein, and vascular endothelial growth factor (VEGF). Vision loss associated with diabetic retinopathy is most commonly caused by DME, which affects approximately 7% of all diabetic patients. Several therapeutic options are available for treating DME. Evidence for the use of these therapies is accumulating; however, the optical treatment choice remains unclear. In recent years, using intravitreal anti-VEGF agents to treat DME has been shown to be beneficial. Anti-VEGF injections are generally considered suitable first-line therapy for center-involved DME and are effective in improving visual acuity (VA), with 10% to 40% of patients achieving significant improvement in best-corrected visual acuity (BCVA) after 1 year of treatment.

The management of DME is complex, and often multiple treatment approaches are needed. Although anti-VEGF agents were effective for the treatment of DME, there is a proportion of patients who do not achieve optimal response to these agents, presenting refractory or persistent DME. Intravitreal administration of steroids for the treatment of DME has also been studied for many years due to their well-known, widespread, anti-inflammatory effects. Dexamethasone implant is a slow-release dexamethasone delivery system developed for intravitreal administration that has recently been introduced as a therapeutic option in DME.

Conditions

Diabetic Retinopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arms

Diabetic macular edema Dexamethasone 0.7mg is injected into the vitreous cavity. Center-involved macular edema secondary to diabetic retinopathy for no longer than 3 months (at the screening visit it should be ensured that the subjects will comply with the criterion of ≤ 3 months since onset of macular edema at their scheduled baseline visit)

Group Type: EXPERIMENTAL

Dexamethasone implant

Intervention Type: DRUG

Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.

Interventions

Dexamethasone implant

Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.

Intervention Type: DRUG

Other Intervention Names

Ozurdex

Eligibility Criteria

Inclusion Criteria

1. Male and females 18 years of age or older

2. Written informed consent has been obtained

3. Diabetic macular edema with a central macular thickness (CMT) ≥ 300um measured by spectral domain optical coherence tomography.

4. Treatment-naïve subjects for diabetic macular edema.

5. Documented BCVA of ETDRS letter score of 23 to 73 letters (Snellen equivalent of 20/320 to 20/40) in the study eye.

Exclusion Criteria

1. Previous panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye

2. Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for diabetic macular edema

3. Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study

4. Previous use of intraocular corticosteroids in the study eye at any time or use of periocular corticosteroids in the study eye within 12 months prior to Day 1

5. Elevated intraocular pressure or a history of steroid-induced ocular hypertension

6. The presence of other retinopathies, maculopathies, visually significant cataract, vitreomacular traction, peripheral ischemia, history of pars plana vitrectomy

7. Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening

8. Any history of allergy to povidone iodine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yeungnam University College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Min Sagong

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Min Sagong, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Yeungnam University Hospital

Locations

Dong-A University Hospital

Busan, , South Korea

Site Status: RECRUITING

Maryknoll Medical Center

Busan, , South Korea

Site Status: RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, , South Korea

Site Status: RECRUITING

Yeungnam university hospital

Daegu, , South Korea

Site Status: RECRUITING

Kyungpook National University Hospital

Daegu, , South Korea

Site Status: RECRUITING

Chungnam National University Hospital

Daejeon, , South Korea

Site Status: RECRUITING

Chonnam National University Hospital

Gwangju, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Min Sagong, MD,PhD

Role: CONTACT

msagong@ynu.ac.kr

82-53-620-3443

Sohee Shin

Role: CONTACT

ey005@ymc.yu.ac.kr

82-53-620-3877

Facility Contacts

Woo Jin Jung, MD,PhD

Role: primary

Jung Min Park, MD,PhD

Role: primary

Yong Seop Han, MD,PhD

Role: primary

Min Sagong, MD,PhD

Role: primary

msagong@ynu.ac.kr

82-53-620-3443

Dong Ho Park, MD,PhD

Role: primary

Jung Yeul Kim, MD,PhD

Role: primary

Yong Sok Ji, MD,PhD

Role: primary

Other Identifiers

YUMC 2020-05-086

Identifier Type: -

Identifier Source: org_study_id