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Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

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ClinicalTrials.gov Identifier: NCT00695318
Recruitment Status : Terminated
First Posted : June 11, 2008
Results First Posted : May 29, 2015
Last Update Posted : May 29, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Fluocinolone Acetonide Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : December 2008
Primary Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: A, 2, I 0.2 µg/Day + Sham
0.2 µg/Day
Drug: Fluocinolone Acetonide
0.2 µg/Day in study eye + Sham in fellow eye
Experimental: A, 2, II 0.5 µg/Day + Sham
0.5 µg/Day
Drug: Fluocinolone Acetonide
0.5 µg/Day in study eye +Sham in fellow eye


Outcome Measures

Primary Outcome Measures :
  1. Change From Baseline in Size of Geographic Atrophy [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00695318


Locations
United States, Michigan
Kresge Eye Institute
Detroit, Michigan, United States
Sponsors and Collaborators
Alimera Sciences
More Information

Responsible Party: Alimera Sciences
ClinicalTrials.gov Identifier: NCT00695318     History of Changes
Other Study ID Numbers: C-01-08-004
First Posted: June 11, 2008    Key Record Dates
Results First Posted: May 29, 2015
Last Update Posted: May 29, 2015
Last Verified: May 2015

Keywords provided by Alimera Sciences:
AMD
Age-Related Macular Degeneration
Geographic Atrophy
GA

Additional relevant MeSH terms:
Macular Degeneration
Atrophy
Geographic Atrophy
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Fluocinolone Acetonide
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs