Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina (FAVOR)

This study has been terminated.
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
First received: October 9, 2008
Last updated: May 8, 2015
Last verified: May 2015
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: Fluocinolone Acetonide
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by Alimera Sciences:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    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.

Enrollment: 20
Study Start Date: May 2009
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fluocinolone Acetonide 0.2 µg/day
0.2 µg/day
Drug: Fluocinolone Acetonide
0.2 µg/day
Experimental: Fluocinolone Acetonide 0.5 µg/day
0.5 µg/day
Drug: Fluocinolone Acetonide
0.5 µg/day


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00770770

United States, Kentucky
University of Kentucky Department of Ophthalmology
Lexington, Kentucky, United States
United States, Massachusetts
Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
United States, Ohio
Cole Eye Institute
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Alimera Sciences
  More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00770770     History of Changes
Other Study ID Numbers: C-01-08-006 
Study First Received: October 9, 2008
Results First Received: April 17, 2015
Last Updated: May 8, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Alimera Sciences:
Macular edema secondary to RVO

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Vascular Diseases
Venous Thrombosis
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 26, 2016