Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina - Full Text View

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

This study is currently recruiting participants.

Verified January 2012 by Alimera Sciences

First Received on October 9, 2008. Last Updated on January 31, 2012 History of Changes

Sponsor:	Alimera Sciences
Information provided by (Responsible Party):	Alimera Sciences
ClinicalTrials.gov Identifier:	NCT00770770

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:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Fluocinolone acetonide

U.S. FDA Resources

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:	November 2012 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00770770

Contacts

Contact: Kathleen Billman

Kathleen.billman@alimerasciences.com

Locations

United States, Kentucky
University of Kentucky Department of Ophthalmology	Recruiting
Lexington, Kentucky, United States
Contact: Michele Reg 859-323-5868 mreg4@email.uky.edu
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States
United States, Ohio
Cole Eye Institute	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Rachel Rusnak 216-445-1256 rusnakr@ccf.org

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:	January 31, 2012
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 May 23, 2012