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

Phase 1

Terminated

• Conditions: Macular Edema
• Interventions: Drug: Dexamethasone Phosphate Ophthalmic

• Registration Number: NCT02485249
• Lead Sponsor: Eyegate Pharmaceuticals, Inc.

Brief 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)

Detailed 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).

Study Timeline

• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Study Start: 2015-07
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• 1. Age 18 to 90 years 2. Have diagnosis of ME secondary to one of the following diagnosed conditions:

  2. 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)

  3. Diabetic macular edema (DME) with a mean CST ≥ 300µm on SD-OCT images taken at the baseline visit (Day 0)

  4. 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

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexamethasone Phosphate	Dexamethasone Phosphate Ophthalmic	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

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Changes in macular volume as evaluated by spectral-domain-optical coherence tomography	Day 4, Day 9, Day 14, and Day 21
Dilated fundus exam	Day 4, Day 9, Day 14, and Day 21
Qualitative review of spectral-domain-optical coherence tomography scans	Day 4, Day 9, Day 14, and Day 21

Trial Locations

Locations (1)

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States