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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00770770
First received: October 9, 2008
Last updated: July 9, 2013
Last verified: July 2013
  Purpose

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 ]

Estimated Enrollment: 20
Study Start Date: May 2009
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
0.2 µg/day
Drug: Fluocinolone Acetonide
0.2 µg/day
Experimental: 2
0.5 µg/day
Drug: Fluocinolone Acetonide
0.5 µg/day

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00770770

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

No publications provided

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
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration

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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014