Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Alimera Sciences
ClinicalTrials.gov Identifier:
NCT00695318
First received: June 9, 2008
Last updated: November 20, 2013
Last verified: November 2013

June 9, 2008
November 20, 2013
December 2008
December 2014   (final data collection date for primary outcome measure)
Change from baseline in size of geographic atrophy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00695318 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Age-Related Macular Degeneration
  • Drug: Fluocinolone Acetonide
    0.2 µg/Day
  • Drug: Fluocinolone Acetonide
    0.5 µg/Day
  • Drug: Sham Injection
    Sham injection
  • Experimental: A, 2, I
    0.2 µg/Day
    Intervention: Drug: Fluocinolone Acetonide
  • Experimental: A, 2, II
    0.5 µg/Day
    Intervention: Drug: Fluocinolone Acetonide
  • Sham Comparator: A, 2, III
    Sham Injection
    Intervention: Drug: Sham Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
December 2014   (final data collection date for primary outcome measure)

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
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00695318
C-01-08-004
No
Alimera Sciences
Alimera Sciences
Not Provided
Not Provided
Alimera Sciences
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP