Macular EdemaPhase 2FAVORNCT00770770
Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
A Phase 2 study testing Fluocinolone Acetonide in people with Macular Edema and Retinal Vein Occlusion, run by Alimera Sciences at 3 sites in United States.
Trial summary
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Fluocinolone Acetonide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Central subfield thickness > 300 μm
- BCVA of ≥ 24 and ≤ 68 letters
- Males and non-pregnant females 18 years and over
Who cannot join
- Macular edema secondary to any condition other than RVO
- Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
- Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
- Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
- Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
- Any change in systemic steroid therapy within 3 months of screening
- History of vitrectomy in the study eye
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Ophthalmic Consultants of Boston
Boston, Massachusetts
Cole Eye Institute
Cleveland, Ohio, 44195
University of Kentucky Department of Ophthalmology
Lexington, Kentucky
About this study
Official title: A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Being tested
- Fluocinolone Acetonide
- Keywords
- Macular edema secondary to RVO
- Medical subject headings
- Macular Edema, Retinal Vein Occlusion
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
Fluocinolone AcetonideDrug
0.5 µg/day
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone Acetonide 0.2 µg/day | Experimental | 0.2 µg/day Receives: Drug: Fluocinolone Acetonide |
| Fluocinolone Acetonide 0.5 µg/day | 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.
Visual Acuity
To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startMay 2009
- 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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 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
- NCT00770770
- Sponsor's protocol ID
- C-01-08-006
- Acronym
- FAVOR
- Status last verified
- May 2015
- First submitted
- 9 Oct 2008
- Last updated
- 28 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 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-masked, Pilot Study of the Safety and Efficacy of 0.5 µg/Day and 0.2 µg/Day Iluvien™ (Fluocinolone Acetonide Intravitreal Insert) 0.19 mg in Subjects With Macular Edema Secondary to Retinal Vein Occlusion
- ClinicalTrials.gov ID
- NCT00770770
- Acronym / sponsor ID
- FAVOR / C-01-08-006
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Keywords
- Macular edema secondary to RVO
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2013 (actual)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Posted 28 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 efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone Acetonide 0.2 µg/day | Experimental | Drug: Fluocinolone Acetonide0.2 µg/day |
| Fluocinolone Acetonide 0.5 µg/day | Experimental | Drug: Fluocinolone Acetonide0.5 µg/day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
- Central subfield thickness > 300 μm
- BCVA of ≥ 24 and ≤ 68 letters
- Males and non-pregnant females 18 years and over
Key exclusion criteria (7 listed)
- Macular edema secondary to any condition other than RVO
- Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
- Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
- Glaucoma or ocular hypertension (IOP > 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
- Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
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 0.2 µg/day |
| Fluocinolone Acetonide0.5 µg/day | Drug | Fluocinolone Acetonide 0.5 µg/day |
Primary outcome
Visual Acuity
Time frame: 3 months
To compare the 3 month best corrected visual acuity to baseline in subjects diagnosed with macular edema secondary to retinal vein occlusion. BCVA will be measured according to the standard procedure developed for ETDRS at 4 meters or 3 meters if the electronic (E)-ETDRS system is employed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 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.
3 sites 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 Macular Edema and Retinal Vein Occlusion, run by Alimera Sciences at 3 sites 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 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 28 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 3 sites 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 28 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?
Visual Acuity (time frame: 3 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 28 May 2015.