Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
First received: June 9, 2008
Last updated: November 20, 2013
Last verified: November 2013

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

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 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, 2, I
0.2 µg/Day
Drug: Fluocinolone Acetonide
0.2 µg/Day
Experimental: A, 2, II
0.5 µg/Day
Drug: Fluocinolone Acetonide
0.5 µg/Day
Sham Comparator: A, 2, III
Sham Injection
Drug: Sham Injection
Sham injection


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

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

United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States
Sponsors and Collaborators
Alimera Sciences
  More Information

No publications provided

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00695318     History of Changes
Other Study ID Numbers: C-01-08-004
Study First Received: June 9, 2008
Last Updated: November 20, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alimera Sciences:
Age-Related Macular Degeneration
Geographic Atrophy

Additional relevant MeSH terms:
Macular Degeneration
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Fluocinolone Acetonide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014