Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema
Macular Edema
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring Iontophoresis, Macular Edema, Ophthalmology
Eligibility Criteria
Inclusion Criteria:
1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following diagnosed conditions:
- Central or branch retinal vein occlusion (CRVO or BRVO) with a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)
- Diabetic macular edema (DME) with a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)
Cystoid macular edema (CME) secondary to having undergone a previous PPV and having a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0) having a history of previous positive response to steroid treatment 3. Receive, understand, and sign a copy of the ICF 4. Be able to return for all study visits and willing to comply with all study related instructions
Exclusion Criteria:
Sites / Locations
- Ophthalmic Consultants of Boston
Arms of the Study
Arm 1
Experimental
Dexamethasone Phosphate
Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 14.0 mA-min at 3.5 mA on Day 0, Day 4, and Day 14