Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Alimera Sciences

Status and phase

Terminated

Phase 2

Conditions

Age-Related Macular Degeneration

Treatments

Drug: Fluocinolone Acetonide

Study type

Interventional

Funder types

Industry

Identifiers

NCT00695318

C-01-08-004

Details and patient eligibility

About

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.

Full 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.

Enrollment

17 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

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