Overview

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