This trial is active, not recruiting.

Condition age-related macular degeneration
Treatments fluocinolone acetonide, sham injection
Phase phase 2
Sponsor Alimera Sciences
Start date December 2008
End date December 2014
Trial size 40 participants
Trial identifier NCT00695318, C-01-08-004


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
0.2 µg/Day
fluocinolone acetonide
0.2 µg/Day
0.5 µg/Day
fluocinolone acetonide
0.5 µg/Day
(Sham Comparator)
Sham Injection
sham injection
Sham injection

Primary Outcomes

Change from baseline in size of geographic atrophy
time frame: 24 months

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Alimera Sciences.