Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Phase 2TerminatedNCT00695318

Alimera Sciences17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Age-Related Macular Degeneration

Interventions

Fluocinolone AcetonideDRUG

0.2 µg/Day in study eye + Sham in fellow eye

Fluocinolone AcetonideDRUG

0.5 µg/Day in study eye +Sham in fellow eye

Eligibility

Sex: ALLMin age: 55 Years

Medical Language ↔ Plain English

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

Locations (1)

Kresge Eye Institute

Detroit, Michigan, United States

Outcomes

Primary Outcomes

Change From Baseline in Size of Geographic Atrophy

Time frame: 24 months

Data from ClinicalTrials.gov

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