Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema (DANTE)

Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema: The Multicenter DANTE Study

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.

Study Overview

• Status: Unknown
• Conditions: Diabetic Retinopathy
• Intervention / Treatment: Drug: Dexamethasone implant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 49
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Min Sagong, MD,PhD; Phone Number: 82-53-620-3443; Email: msagong@ynu.ac.kr
• Study Contact Backup: Name: Sohee Shin; Phone Number: 82-53-620-3877; Email: ey005@ymc.yu.ac.kr

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Recruiting
    • Dong-A University Hospital
    • Contact: Woo Jin Jung, MD,PhD
  • Busan, Korea, Republic of
    • Recruiting
    • Maryknoll Medical Center
    • Contact: Jung Min Park, MD,PhD
  • Changwon, Korea, Republic of
    • Recruiting
    • Gyeongsang National University Changwon Hospital
    • Contact: Yong Seop Han, MD,PhD
  • Daegu, Korea, Republic of
    • Recruiting
    • Kyungpook National University Hospital
    • Contact: Dong Ho Park, MD,PhD
  • Daegu, Korea, Republic of, 42415
    • Recruiting
    • Yeungnam University Hospital
    • Contact: Min Sagong, MD,PhD; Phone Number: 82-53-620-3443; Email: msagong@ynu.ac.kr
  • Daejeon, Korea, Republic of
    • Recruiting
    • Chungnam National University Hospital
    • Contact: Jung Yeul Kim, MD,PhD
  • Gwangju, Korea, Republic of
    • Recruiting
    • Chonnam National University Hospital
    • Contact: Yong Sok Ji, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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)	Drug: Dexamethasone implant; Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.; Other Names: Ozurdex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of best corrected visual acuity	The mean change of best corrected visual acuity from baseline to Month 6 in early treatment diabetic retinopathy (ETDRS) letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart	From baseline to month 6

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of best corrected visual acuity	The change in mean best corrected visual acuity at baseline as measured by the early treatment diabetic retinopathy letter score by using Logarithm of the Minimum Angle of Resolution (LogMAR) chart	From baseline to month 12
Mean change in central macular thickness	The mean change in central macular thickness (um) by using optical coherence tomography	From baseline to month 6 and 12
Mean number of injections	The mean number of injections	From baseline to month 12
Mean treatment interval between injections	The mean treatment interval (weeks) between injections	From baseline to month 12
Proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity	The proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity on the early treatment diabetic retinopathy chart	Compared with baseline at month 6 and 12
Changes of total area (mm^2)of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography	Changes of total area (mm^2) of nonperfusion within the ETDRS grid using fluorescein angiography and optical coherence tomography angiography	From baseline to month 12

Collaborators and Investigators

• Sponsor: Yeungnam University College of Medicine
• Investigators: Principal Investigator: Min Sagong, MD,PhD, Yeungnam University Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): June 22, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: May 25, 2020
• First Submitted That Met QC Criteria: June 23, 2020
• First Posted (Actual): June 26, 2020

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 23, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Diabetic Retinopathy; Macular Edema; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• Other Study ID Numbers: YUMC 2020-05-086

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No