Fluocinolone Acetonide Intravitreal Inserts for Vein Occlusion in Retina

NCT ID: NCT00770770

Last Updated: 2015-05-28

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Brief Summary

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This study will assess the safety and efficacy of FA Intravitreal Inserts in subjects with macular edema secondary to RVO.

Detailed Description

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Conditions

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Macular Edema Retinal Vein Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluocinolone Acetonide 0.2 µg/day

0.2 µg/day

Group Type EXPERIMENTAL

Fluocinolone Acetonide

Intervention Type DRUG

0.2 µg/day

Fluocinolone Acetonide 0.5 µg/day

0.5 µg/day

Group Type EXPERIMENTAL

Fluocinolone Acetonide

Intervention Type DRUG

0.5 µg/day

Interventions

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Fluocinolone Acetonide

0.2 µg/day

Intervention Type DRUG

Fluocinolone Acetonide

0.5 µg/day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of macular edema due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
* Central subfield thickness \> 300 μm
* BCVA of ≥ 24 and ≤ 68 letters
* Males and non-pregnant females 18 years and over

Exclusion Criteria

* Macular edema secondary to any condition other than RVO
* Presence of foveal atrophy, dense pigmentary changes or dense subfoveal exudates in the study eye
* Cystic intraretinal hemorrhage involving the fovea in the study eye that is responsible for vision loss
* Glaucoma or ocular hypertension (IOP \> 21 mmHg or concurrent therapy at screening with IOP-lowering agents)
* Any prior treatment with intravitreal, subtenon, or periocular steroid or anti-VEGF therapy since the diagnosis of RVO in the study eye
* Any change in systemic steroid therapy within 3 months of screening
* History of vitrectomy in the study eye
Minimum Eligible Age

18 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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University of Kentucky Department of Ophthalmology

Lexington, Kentucky, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Cole Eye Institute

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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C-01-08-006

Identifier Type: -

Identifier Source: org_study_id

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