A Study of the Safety and Efficacy of SK-0503 for Diabetic Macular Edema

NCT ID: NCT00308542

Last Updated: 2012-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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This study will evaluate the safety and efficacy of intravitreal implant of dexamethasone for the treatment of diabetic edema.

Detailed Description

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Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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dexamethasone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Diabetic macular edema
* Criteria for visual acuity and macular thickness are met

Exclusion Criteria

* History of glaucoma
* Known steroid-responder
* Use of systemic steroids
* Use of Warfarin/Heparin
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanwa Kagaku Kenkyusho Co., Ltd.

INDUSTRY

Sponsor Role lead

Principal Investigators

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Clinical Study Group, Clinical Development Dept.

Role: STUDY_DIRECTOR

Sanwa Kagaku Kenkyusho Co., Ltd.

Locations

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Aichi, , Japan

Site Status

Chiba, , Japan

Site Status

Fukuoka, , Japan

Site Status

Gunma, , Japan

Site Status

Hokkaido, , Japan

Site Status

Kagawa, , Japan

Site Status

Kyoto, , Japan

Site Status

Mie, , Japan

Site Status

Miyazaki, , Japan

Site Status

Osaka, , Japan

Site Status

Shiga, , Japan

Site Status

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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DX4002

Identifier Type: -

Identifier Source: org_study_id

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