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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00770770
Recruitment Status : Terminated
First Posted : October 10, 2008
Results First Posted : May 28, 2015
Last Update Posted : May 28, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Condition or disease Intervention/treatment Phase
Macular Edema Retinal Vein Occlusion Drug: Fluocinolone Acetonide Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
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
Study Start Date : May 2009
Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00770770


Locations
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
First Posted: October 10, 2008    Key Record Dates
Results First Posted: May 28, 2015
Last Update Posted: May 28, 2015
Last Verified: May 2015

Keywords provided by Alimera Sciences:
Macular edema secondary to RVO

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