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Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

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

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

Inclusion Criteria:

Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies.
In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN.
Ability and willingness to comply with the treatment and follow up procedures.
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:

Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD)
Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye
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)
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)
Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids
History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure
History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up
Any lens opacity which significantly impairs vision, in the opinion of the investigator.
Peripheral retinal detachment in prospective area of insertion
Participation in another clinical trial within 12 weeks before the screening visit or during the study

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fluocinolone Acetonide

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01304706

First Posted

February 24, 2011

Last Updated

April 17, 2015

Sponsor

Alimera Sciences

1. Study Identification

Unique Protocol Identification Number

NCT01304706

Brief Title

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

Study Type

Interventional

2. Study Status

Record Verification Date

April 2015

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alimera Sciences

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with 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

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Fluocinolone Acetonide

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Fluocinolone Acetonide

Intervention Description

0.2 μg/day

Primary Outcome Measure Information:

Title

Number of Participants With Adverse Events

Description

This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.

Time Frame

12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects who previously participated in the FAME studies and subjects with chronic DME considered insufficiently responsive to available therapies. In the judgment of the Investigator, the subject will benefit from treatment with ILUVIEN. Ability and willingness to comply with the treatment and follow up procedures. 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: Pregnant, lactating females or females of childbearing potential (unless using reliable contraception, i.e. double barrier, surgical sterilization, oral contraceptives, Norplant, intrauterine device (IUD) Glaucoma, defined as glaucomatous anatomical changes of the optic disc and/or visual field changes at screening in the study eye 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) 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) Known or suspected hypersensitivity to any of the ingredients of the investigational product or to other corticosteroids History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy or IOP-lowering procedure History or presence of any disease or condition (malignancy) that in the investigator's opinion would preclude study treatment or follow-up Any lens opacity which significantly impairs vision, in the opinion of the investigator. Peripheral retinal detachment in prospective area of insertion Participation in another clinical trial within 12 weeks before the screening visit or during the study

Facility Information:

City

Alpharetta

State/Province

Georgia

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study

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