Study Stopped
Slow enrollment
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
1 other identifier
interventional
25
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jul 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2015
CompletedFirst Posted
Study publicly available on registry
June 30, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedAugust 3, 2016
August 1, 2016
11 months
June 26, 2015
August 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Changes in macular volume as evaluated by spectral-domain-optical coherence tomography
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
Dilated fundus exam
Day 4, Day 9, Day 14, and Day 21
Study Arms (1)
Dexamethasone Phosphate
EXPERIMENTALDexamethasone 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
Interventions
Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
Eligibility Criteria
You may qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Lisa Brandano
EyeGate
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2015
First Posted
June 30, 2015
Study Start
July 1, 2015
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
August 3, 2016
Record last verified: 2016-08