This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback
Trial record 4 of 16 for:    Iluvien macular | macular degeneration

Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

This study has been terminated.
Information provided by (Responsible Party):
Alimera Sciences Identifier:
First received: June 9, 2008
Last updated: May 11, 2015
Last verified: May 2015
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 Intervention Phase
Age-Related Macular Degeneration Drug: Fluocinolone Acetonide Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Alimera Sciences:

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

Enrollment: 17
Study Start Date: December 2008
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00695318

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

Responsible Party: Alimera Sciences Identifier: NCT00695318     History of Changes
Other Study ID Numbers: C-01-08-004
Study First Received: June 9, 2008
Results First Received: April 17, 2015
Last Updated: May 11, 2015

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

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Fluocinolone Acetonide
Geographic Atrophy
Retinal Diseases
Eye Diseases
Pathological Conditions, Anatomical
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs processed this record on September 21, 2017