Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy - Full Text View

Sponsored by:	Alimera Sciences
Information provided by:	Alimera Sciences
ClinicalTrials.gov Identifier:	NCT00695318

Purpose

This study will compare the safety and efficacy of Medidur FA treatment in one eye to the sham-treated fellow eye of subjects with geographic atrophy secondary to AMD.

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: Fluocinolone Acetonide Drug: Sham Injection	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Fluocinolone Fluocinolone acetonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Masked, Fellow-Eye Comparison Of The Safety And Efficacy Of 0.2 And 0.5 µg/Day Fluocinolone Acetonide Intravitreal Insert To Sham Injection In Subjects With Bilateral Geographic Atrophy Due To AMD

Further study details as provided by Alimera Sciences:

Primary Outcome Measures:

Change from baseline in size of geographic atrophy [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A, 2, I: Experimental 0.2 µg/Day	Drug: Fluocinolone Acetonide 0.2 µg/Day
A, 2, II: Experimental 0.5 µg/Day	Drug: Fluocinolone Acetonide 0.5 µg/Day
A, 2, III: Sham Comparator Sham Injection	Drug: Sham Injection Sham injection

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Clinical diagnosis bilateral GA secondary to AMD of ≥ 0.5 and ≤ 7 MPS disc areas
Males and non-pregnant females 55 years old or older

Exclusion Criteria:

GA secondary to any condition other than AMD in either eye
History of or current CNV in either eye or the need for anti-angiogenic therapy
Glaucoma or ocular hypertension (IOP > 21 mmHg OR concurrent therapy at screening with IOP-lowering agents) in either eye
Treatment with intravitreal, subtenon, or periocular steroid within 6 months prior to enrollment in either eye
Any change in systemic steroid therapy within 3 months of screening
History of vitrectomy in either eye
Any ocular surgery within 12 weeks of screening in either eye

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00695318

Locations

United States, Michigan
Kresge Eye Institute	Recruiting
Detroit, Michigan, United States
Contact: Laura Schulz lschulz@med.wayne.edu

Sponsors and Collaborators

Alimera Sciences

More Information

Responsible Party:	Alimera Sciences, Inc. ( Kathleen Billman )
Study ID Numbers:	C-01-08-004
Study First Received:	June 9, 2008
Last Updated:	December 11, 2008
ClinicalTrials.gov Identifier:	NCT00695318
Health Authority:	United States: Food and Drug Administration

Keywords provided by Alimera Sciences:

AMD
Age-Related Macular Degeneration
Geographic Atrophy
GA

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Fluocinolone Acetonide
Eye Diseases
Retinal Degeneration

Macular Degeneration
Atrophy
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

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

Hormones
Glucocorticoids
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009