Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: October 2013

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.

Interventions

  • Drug: Fluocinolone Acetonide
    • 0.2 µg/Day in study eye + Sham in fellow eye
  • Drug: Fluocinolone Acetonide
    • 0.5 µg/Day in study eye +Sham in fellow eye

Arms, Groups and Cohorts

  • Experimental: A, 2, I 0.2 µg/Day + Sham
    • 0.2 µg/Day
  • Experimental: A, 2, II 0.5 µg/Day + Sham
    • 0.5 µg/Day

Clinical Trial Outcome Measures

Primary Measures

  • Change From Baseline in Size of Geographic Atrophy
    • Time Frame: 24 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alimera Sciences
  • Provider of Information About this Clinical Study
    • Sponsor

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