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

Description

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)

Study Start Date

July 2015

Estimated Completion Date

August 2016

Interventions

  • Drug: Dexamethasone Phosphate Ophthalmic

Specialties

  • Ophthalmology: Clinical Pharmacology,Retina
  • Physician Assistant: Ophthalmology

MeSH Terms

  • Dexamethasone 21-phosphate
  • Edema
  • Macular Degeneration
  • Macular Edema

Study ID

Eyegate Pharmaceuticals, Inc. -- EGP-437-007

Status

Unknown

Trial ID

NCT02485249

Study Type

Interventional

Trial Phase

Phase 1/Phase 2

Enrollment Quota

20

Sponsor

Eyegate Pharmaceuticals, Inc.

Inclusion Criteria

  • 1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following diagnosed conditions: 1. 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) 2. Diabetic macular edema (DME) with a mean CST ? 300µm on SD-OCT images taken at the baseline visit (Day 0) 3. 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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Ophthalmic Consultants of Boston - Boston, Massachusetts 2.8 miles None None None

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