Fluocinolone Acetonide Intravitreal Inserts in Geographic Atrophy

NCT ID: NCT00695318

Last Updated: 2015-05-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Brief Summary

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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

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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.

Conditions

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Age-Related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A, 2, I 0.2 µg/Day + Sham

0.2 µg/Day

Group Type EXPERIMENTAL

Fluocinolone Acetonide

Intervention Type DRUG

0.2 µg/Day in study eye + Sham in fellow eye

A, 2, II 0.5 µg/Day + Sham

0.5 µg/Day

Group Type EXPERIMENTAL

Fluocinolone Acetonide

Intervention Type DRUG

0.5 µg/Day in study eye +Sham in fellow eye

Interventions

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Fluocinolone Acetonide

0.2 µg/Day in study eye + Sham in fellow eye

Intervention Type DRUG

Fluocinolone Acetonide

0.5 µg/Day in study eye +Sham in fellow eye

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alimera Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kresge Eye Institute

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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C-01-08-004

Identifier Type: -

Identifier Source: org_study_id

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