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Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Fluocinolone Acetonide

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

John Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Retinal Thickness

Full Information

NCT ID

NCT00490815

First Posted

June 21, 2007

Last Updated

January 17, 2014

Sponsor

Alimera Sciences

1. Study Identification

Unique Protocol Identification Number

NCT00490815

Brief Title

Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alimera Sciences

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

37 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fluocinolone Acetonide

Intervention Description

0.5 mg fluocinolone acetonide intravitreal insert

Intervention Type

Drug

Intervention Name(s)

Fluocinolone Acetonide

Intervention Description

0.2 mg fluocinolone acetonide intravitreal insert

Primary Outcome Measure Information:

Title

Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor

Description

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.

Time Frame

over 36 months

Secondary Outcome Measure Information:

Title

Retinal Thickness

Time Frame

over 36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Facility Information:

Facility Name

John Hopkins University

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema

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