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Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

Primary Purpose

Age-Related Macular Degeneration

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Fluocinolone Acetonide
Fluocinolone Acetonide
Sponsored by
Alimera Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, Age-Related Macular Degeneration, Geographic Atrophy, GA

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kresge Eye Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

A, 2, I 0.2 µg/Day + Sham

A, 2, II 0.5 µg/Day + Sham

Arm Description

0.2 µg/Day

0.5 µg/Day

Outcomes

Primary Outcome Measures

Change From Baseline in Size of Geographic Atrophy

Secondary Outcome Measures

Full Information

First Posted
June 9, 2008
Last Updated
May 11, 2015
Sponsor
Alimera Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00695318
Brief Title
Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy
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 Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alimera Sciences

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Age-Related Macular Degeneration, Geographic Atrophy, GA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A, 2, I 0.2 µg/Day + Sham
Arm Type
Experimental
Arm Description
0.2 µg/Day
Arm Title
A, 2, II 0.5 µg/Day + Sham
Arm Type
Experimental
Arm Description
0.5 µg/Day
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
0.2 µg/Day in study eye + Sham in fellow eye
Intervention Type
Drug
Intervention Name(s)
Fluocinolone Acetonide
Intervention Description
0.5 µg/Day in study eye +Sham in fellow eye
Primary Outcome Measure Information:
Title
Change From Baseline in Size of Geographic Atrophy
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kresge Eye Institute
City
Detroit
State/Province
Michigan
Country
United States

12. IPD Sharing Statement

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Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

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