Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema

Diabetic Retinopathy Clinical Trial

— DANTE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448496
• Other study ID #: YUMC 2020-05-086
• Status: Recruiting
• Phase: Phase 4
• Start date: June 22, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2020
• Source: Yeungnam University College of Medicine
• Contact: Min Sagong, MD,PhD
• Phone: 82-53-620-3443
• Email: msagong[@]ynu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 49
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 signi?cant 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

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Macular Edema

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Dong-A University Hospital	Busan
Korea, Republic of	Maryknoll Medical Center	Busan
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeungnam university hospital	Daegu
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Chonnam National University Hospital	Gwangju

Sponsors (1)

Lead Sponsor	Collaborator
Yeungnam University College of Medicine

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Mean number of injections	The mean number of injections	From baseline to month 12
Secondary	Mean treatment interval between injections	The mean treatment interval (weeks) between injections	From baseline to month 12
Secondary	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
Secondary	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