Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304706
• Other study ID #: C-01-11-008
• Status: Completed
• Phase: Phase 3
• First received: February 24, 2011
• Last updated: April 17, 2015
• Start date: April 2011

Study information

• Verified date: April 2015
• 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 assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.

2. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.

3. Ability and willingness to comply with the treatment and follow up procedures.

4. Ability to understand and sign the Informed Consent Form. No expectation that subject will be moving out of the area of the clinical center to an area not covered by another clinical center during the next 12 months.

Exclusion Criteria:

1. Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)

2. Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye

3. Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g., presumed ocular histoplasmosis, high myopia (spherical equivalent > 8 diopters), macular degeneration)

4. Any active viral, fungal or bacterial disease of the cornea or conjunctiva or any history of a potentially recurrent infection which could be activated by treatment with a steroid, (e.g., ocular herpes simplex virus)

5. Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids

6. History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure

7. History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up

8. Any lens opacity which significantly impairs vision, in the opinion of the investigator.

9. Peripheral retinal detachment in prospective area of insertion

10. Participation in another clinical trial within 12 weeks before the screening visit or during the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• Fluocinolone Acetonide
0.2 µg/day

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alimera Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events	This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.	12 months	Yes