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

Diabetic Macular Edema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00490815
• Other study ID #: C-01-06-002
• Status: Completed
• Phase: Phase 3
• First received: June 21, 2007
• Last updated: January 17, 2014
• Start date: August 2007
• Est. completion date: April 2011

Study information

• Verified date: January 2014
• Source: Alimera Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: April 2011
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Fluocinolone Acetonide
0.5 mg fluocinolone acetonide intravitreal insert
• Fluocinolone Acetonide
0.2 mg fluocinolone acetonide intravitreal insert

Locations

Country	Name	City	State
United States	John Hopkins University	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Retinal Thickness		over 36 months	No