Overview

Prospective Trial of Dexamethasone implAnt for Treatment Naïve diabeTic Macular Edema

Status:
Recruiting

Trial end date:
2021-12-31

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Yeungnam University College of Medicine

Treatments:

Dexamethasone

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