Diabetic Macular EdemaPhase 3NCT01304706
Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
A Phase 3 study testing Fluocinolone Acetonide in people with Diabetic Macular Edema, run by Alimera Sciences at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Fluocinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Nov 2013
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- Fluocinolone Acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone AcetonideDrug
0.2 μg/day
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone Acetonide | Experimental | Not described Receives: Drug: Fluocinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startApr 2011
- Primary completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304706
- Sponsor's protocol ID
- C-01-11-008
- Status last verified
- Apr 2015
- First submitted
- 24 Feb 2011
- Last updated
- 4 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluocinolone Acetonide in Diabetic Macular Edema (FAME) Extension Study
- ClinicalTrials.gov ID
- NCT01304706
- Acronym / sponsor ID
- C-01-11-008
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Nov 2013 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Posted 4 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess the safety and utility of the new inserter for the administration of ILUVIEN in subjects with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone Acetonide | Experimental | Drug: Fluocinolone Acetonide |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluocinolone Acetonide0.2 μg/day | Drug | Fluocinolone Acetonide |
Primary outcome
Number of Participants With Adverse Events
Time frame: 12 months
This is a measurement of the number of subjects who experienced an adverse event and/or a serious adverse event during the trial.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluocinolone Acetonide in people with Diabetic Macular Edema, run by Alimera Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2015.