Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
1 other identifier
interventional
37
1 country
1
Brief Summary
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2007
Typical duration for phase_3
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 21, 2007
CompletedFirst Posted
Study publicly available on registry
June 25, 2007
CompletedStudy Start
First participant enrolled
August 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedResults Posted
Study results publicly available
February 13, 2014
CompletedFebruary 13, 2014
January 1, 2014
2.1 years
June 21, 2007
September 27, 2013
January 17, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
This was a combined assessment of the levels of fluocinolone acetonide in the plasma and aqueous humor. The average values of the data collected is entered in Outcome Data.
over 36 months
Secondary Outcomes (1)
Retinal Thickness
over 36 months
Study Arms (2)
1
EXPERIMENTAL2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age \>= 18 years with diabetic macular edema
- Diagnosis of diabetes mellitus types 1 or 2
- Best corrected visual acuity of ≥ 19 letters
- Retinal thickness \> 250 microns by OCT
- Investigator is comfortable deferring macular laser treatment for 6 weeks
You may not qualify if:
- Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
- Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
- Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
- Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
- Any ocular surgery within the last 3 months
- Retinal laser treatment within the last 3 months
- History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
- Any lens opacity which impairs visualization of the posterior pole
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alimera Scienceslead
Study Sites (1)
John Hopkins University
Baltimore, Maryland, 21287, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Billman, Senior Director of Scientific Affairs
- Organization
- Alimera Sciences, Inc
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2007
First Posted
June 25, 2007
Study Start
August 1, 2007
Primary Completion
September 1, 2009
Study Completion
April 1, 2011
Last Updated
February 13, 2014
Results First Posted
February 13, 2014
Record last verified: 2014-01