Age-Related Macular DegenerationPhase 2NCT00695318
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
A Phase 2 study testing Fluocinolone Acetonide in people with Age-Related Macular Degeneration, run by Alimera Sciences at 1 site in United States.
Trial summary
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- Fluocinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2013
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
- Males and non-pregnant females 55 years old or older
Who cannot join
- GA secondary to any condition other than AMD in either eye
- History of or current CNV in either eye or the need for anti-angiogenic therapy
- Glaucoma or ocular hypertension (IOP > 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
- Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
- Any change in systemic steroid therapy within 3 months of screening
- History of vitrectomy in either eye
- Any ocular surgery within 12 weeks of screening in either eye
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD
This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
Read the detailed description
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- Fluocinolone Acetonide
- Keywords
- AMD, Age-Related Macular Degeneration, Geographic Atrophy, GA
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
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 in study eye + Sham in fellow eye
Fluocinolone AcetonideDrug
0.5 µg/Day in study eye +Sham in fellow eye
| Study group | Role | What they receive |
|---|---|---|
| A, 2, I 0.2 µg/Day + Sham | Experimental | 0.2 µg/Day Receives: Drug: Fluocinolone Acetonide |
| A, 2, II 0.5 µg/Day + Sham | Experimental | 0.5 µg/Day Receives: Drug: Fluocinolone Acetonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Size of Geographic Atrophy
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2008 (estimated)
- Study startDec 2008
- Primary completionOct 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 Age-Related Macular DegenerationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 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
- NCT00695318
- Sponsor's protocol ID
- C-01-08-004
- Status last verified
- May 2015
- First submitted
- 9 Jun 2008
- Last updated
- 29 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 29 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD
- ClinicalTrials.gov ID
- NCT00695318
- Acronym / sponsor ID
- C-01-08-004
- Conditions
- Age-Related Macular Degeneration
- Keywords
- AMD, Age-Related Macular Degeneration, Geographic Atrophy, GA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Oct 2013 (actual)
- First posted
- 11 Jun 2008 (estimated)
- Results
- Posted 29 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 compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.
Detailed description
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, 2, I 0.2 µg/Day + Sham | Experimental | Drug: Fluocinolone Acetonide0.2 µg/Day |
| A, 2, II 0.5 µg/Day + Sham | Experimental | Drug: Fluocinolone Acetonide0.5 µg/Day |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
- Males and non-pregnant females 55 years old or older
Key exclusion criteria (7 listed)
- GA secondary to any condition other than AMD in either eye
- History of or current CNV in either eye or the need for anti-angiogenic therapy
- Glaucoma or ocular hypertension (IOP > 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
- Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
- Any change in systemic steroid therapy within 3 months of screening
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 in study eye + Sham in fellow eye | Drug | A, 2, I 0.2 µg/Day + Sham |
| Fluocinolone Acetonide0.5 µg/Day in study eye +Sham in fellow eye | Drug | A, 2, II 0.5 µg/Day + Sham |
Primary outcome
Change From Baseline in Size of Geographic Atrophy
Time frame: 24 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 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 2 study testing Fluocinolone Acetonide in people with Age-Related Macular Degeneration, 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 2 inclusion and 7 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: stopped early, as of the sponsor's last update on 29 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 29 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?
Change From Baseline in Size of Geographic Atrophy (time frame: 24 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 29 May 2015.