Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

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

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.

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.

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