Diabetic Macular EdemaPhase 3NCT00490815
Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
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 evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2007to Apr 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
This study will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of 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
0.5 mg fluocinolone acetonide intravitreal insert
Fluocinolone AcetonideDrug
0.2 mg fluocinolone acetonide intravitreal insert
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Fluocinolone Acetonide |
| 2 | Experimental | Not described Receives: Drug: Fluocinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over 36 months
Secondary outcomes (1)
Retinal Thickness
Measured: over 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2007 (estimated)
- Study startAug 2007
- Primary completionSep 2009
- Study completionApr 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 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
- NCT00490815
- Sponsor's protocol ID
- C-01-06-002
- Status last verified
- Jan 2014
- First submitted
- 21 Jun 2007
- Last updated
- 13 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00490815
- Acronym / sponsor ID
- C-01-06-002
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Jun 2007 (estimated)
- Results
- Posted 13 Feb 2014
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 evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Fluocinolone Acetonide |
| 2 | Experimental | Drug: Fluocinolone Acetonide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 Acetonide0.5 mg fluocinolone acetonide intravitreal insert | Drug | 1 |
| Fluocinolone Acetonide0.2 mg fluocinolone acetonide intravitreal insert | Drug | 2 |
Primary outcome
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
Time frame: over 36 months
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.
1 secondary outcome
Retinal Thickness
Time frame: over 36 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2014.
- 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 5 inclusion and 8 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 13 Feb 2014. 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 13 Feb 2014). 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?
Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor (time frame: over 36 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 13 Feb 2014.