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 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02485249
• Other study ID #: EGP-437-007
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: June 26, 2015
• Last updated: August 1, 2016
• Start date: July 2015
• Est. completion date: June 2016

Study information

• Verified date: August 2016
• Source: Eyegate Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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)

Description:

This will be a Phase 1b/2a, exploratory, open-label study, in which up to 20 eligible ME patients will be enrolled at up to 5 clinical sites in the U.S. Twenty eyes of 20 patients will be enrolled which means that only one eye will be treated with study treatment in patients who present at Visit 1 with bilateral ME. In situations where both eyes of a patient are eligible for the study, the eye with the shorter duration of ME will be the study eye.9 The investigator will designate the study eye when both eligible eyes have been diagnosed with ME at the same time. Potential patients who are interested in participating in the study will be provided an informed consent form (ICF) prior to screening. Patient eligibility will be assessed at Visit 1 (Day 0), the baseline visit, by spectral SD-OCT and measurement of IOP, in addition to review of the patient's medical and ophthalmic history and recent concomitant medications history. Study Treatment will be administered on Day 0, Day 4, and Day 9 (Visits 1, 2, and 3). Subjects will be scheduled to return to the clinic for post-treatment assessments during Visits 4 and 5 (Day 14 and Day 21 or Day 28).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema

Intervention

Drug:
• Dexamethasone Phosphate Ophthalmic
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)

Locations

Country	Name	City	State
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eyegate Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomic improvement measured as reduction in mean central subfield thickness as evaluated by spectral-domain-optical coherence tomography		Day 4, Day 9, Day 14, and Day 21	No
Secondary	Changes in macular volume as evaluated by spectral-domain-optical coherence tomography		Day 4, Day 9, Day 14, and Day 21	No
Secondary	Qualitative review of spectral-domain-optical coherence tomography scans		Day 4, Day 9, Day 14, and Day 21	No
Secondary	Dilated fundus exam		Day 4, Day 9, Day 14, and Day 21	No