This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been terminated.
Information provided by (Responsible Party):
Alimera Sciences 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 (Participant, 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 ]
    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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its 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 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

Keywords provided by Alimera Sciences:
Macular edema secondary to RVO

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Fluocinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017