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

Stopped early · Phase 1/Phase 2

Conditions studied: Macular Edema

In brief

To evaluate the safety and efficacy of ocular iontophoresis with dexamethasone phosphate ophthalmic solution, EGP-437, using the EyeGate® II Drug Delivery System (EGDS) in patients with macular edema (ME)

Key facts

Study ID

NCT02485249

Run by

Eyegate Pharmaceuticals, Inc.

People needed

25

Starts

2015-07-01

Expected to finish

2016-06-01

Last updated by the study team

2016-08-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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