Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina
FAVOR
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
1 other identifier
interventional
20
1 country
3
Brief Summary
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2008
CompletedFirst Posted
Study publicly available on registry
October 10, 2008
CompletedStudy Start
First participant enrolled
May 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedResults Posted
Study results publicly available
May 28, 2015
CompletedMay 28, 2015
May 1, 2015
4.4 years
October 9, 2008
April 17, 2015
May 8, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 months
Study Arms (2)
Fluocinolone Acetonide 0.2 µg/day
EXPERIMENTAL0.2 µg/day
Fluocinolone Acetonide 0.5 µg/day
EXPERIMENTAL0.5 µg/day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alimera Scienceslead
Study Sites (3)
University of Kentucky Department of Ophthalmology
Lexington, Kentucky, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
Cole Eye Institute
Cleveland, Ohio, 44195, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kathleen Billman, Senior Director, Scientific Affairs
- Organization
- Alimera Sciences, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2008
First Posted
October 10, 2008
Study Start
May 1, 2009
Primary Completion
October 1, 2013
Last Updated
May 28, 2015
Results First Posted
May 28, 2015
Record last verified: 2015-05