Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alimera Sciences
• Treatments: Fluocinolone Acetonide

Criteria

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