DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017