Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Phase 2
Terminated
- Conditions
- Age-Related Macular Degeneration
- Interventions
- Registration Number
- NCT00695318
- Lead Sponsor
- Alimera Sciences
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A, 2, I 0.2 µg/Day + Sham Fluocinolone Acetonide 0.2 µg/Day A, 2, II 0.5 µg/Day + Sham Fluocinolone Acetonide 0.5 µg/Day
- Primary Outcome Measures
Name Time Method Change From Baseline in Size of Geographic Atrophy 24 months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States