Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
Information source: Alimera Sciences
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Age-Related Macular Degeneration
Intervention: Fluocinolone Acetonide (Drug); Fluocinolone Acetonide (Drug)
Phase: Phase 2
Status: Terminated
Sponsored by: Alimera Sciences
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.
Clinical Details
Official title: 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in Size of Geographic Atrophy
Detailed 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.
Eligibility
Minimum age: 55 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Kresge Eye Institute, Detroit, Michigan, United States
Additional Information
Starting date: December 2008
Last updated: May 11, 2015
|