Status:
TERMINATED
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Lead Sponsor:
Alimera Sciences
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
55+ years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Each patient received a sham injection in one eye and active treatment in the other eye. The eye receiving active treatment was selected based on a randomization schedule.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00695318
Start Date
December 1 2008
Last Update
May 29 2015
Active Locations (1)
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1
Kresge Eye Institute
Detroit, Michigan, United States