Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema

NCT04448496 | Unknown Phase 4 DMC

• 1 other identifier: YUMC 2020-05-086
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 7

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.

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean change of best corrected visual acuity

  From baseline to month 12

• Mean change in central macular thickness

  From baseline to month 6 and 12

• Mean number of injections

  From baseline to month 12

• Mean treatment interval between injections

  From baseline to month 12

• Proportion (%) of subjects who gain ≥ 15 letters in best corrected visual acuity

  Compared with baseline at month 6 and 12

Study Arms (1)

Arms

EXPERIMENTAL

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

Interventions

Dexamethasone implant DRUG

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

Also known as: Ozurdex

Arms

Eligibility Criteria

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

You may qualify if:

• Male and females 18 years of age or older
• Written informed consent has been obtained
• Diabetic macular edema with a central macular thickness (CMT) ≥ 300um measured by spectral domain optical coherence tomography.
• Treatment-naïve subjects for diabetic macular edema.
• Documented BCVA of ETDRS letter score of 23 to 73 letters (Snellen equivalent of 20/320 to 20/40) in the study eye.

You may not qualify if:

• Previous panretinal photocoagulation (PRP) or macular laser photocoagulation in the study eye
• Any prior or concomitant ocular treatment (e.g. anti-VEGF therapy, corticosteroids) in the study eye for diabetic macular edema
• Prior systemic anti-VEGF or corticosteroid therapy, investigational or approved, within the last 3 months before the first dose in the study
• 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
• Elevated intraocular pressure or a history of steroid-induced ocular hypertension
• The presence of other retinopathies, maculopathies, visually significant cataract, vitreomacular traction, peripheral ischemia, history of pars plana vitrectomy
• Any active intraocular, extraocular, and periocular inflammation or infection in either eye within 4 weeks of screening
• Any history of allergy to povidone iodine

Sponsors & Collaborators

• Yeungnam University College of Medicine: lead

Study Sites (7)

Dong-A University Hospital

Busan, South Korea

RECRUITING

Maryknoll Medical Center

Busan, South Korea

RECRUITING

Gyeongsang National University Changwon Hospital

Changwon, South Korea

RECRUITING

Yeungnam university hospital

Daegu, 42415, South Korea

RECRUITING

Kyungpook National University Hospital

Daegu, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

Chonnam National University Hospital

Gwangju, South Korea

RECRUITING

MeSH Terms

Conditions

Diabetic Retinopathy

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Min Sagong, MD,PhD

  Yeungnam University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Min Sagong, MD,PhD

CONTACT

82-53-620-3443; msagong@ynu.ac.kr

Sohee Shin

CONTACT

82-53-620-3877; ey005@ymc.yu.ac.kr

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: Professor

Study Record Dates

• First Submitted: May 25, 2020
• First Posted: June 26, 2020
• Study Start: June 22, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

KR (7)