A Study of the Safety and Efficacy of a New Treatment for... | NCT00308477 | Trialant

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A Study of the Safety and Efficacy of a New Treatment for... | NCT00308477 | Trialant

Studies
A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

NCT00308477

Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.

Status

Completed

Last Update Posted

Feb 13, 2012Estimated

Enrollment

Not provided

Phase

Phase 1Phase 2

Conditions

Macular Degeneration
Macular Edema
Branch Retinal Vein Occlusion

Interventions

dexamethasone

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

NCT00308477

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

DX4001

Secondary IDs

Not provided

Brief Title

A Study of the Safety and Efficacy of a New Treatment for Macular Edema Resulting From Branch Retinal Vein Occlusion

Official Title

Not provided

Acronym

Not provided

Organization

Sanwa Kagaku Kenkyusho Co., Ltd.INDUSTRY

Status Module

Record Verification Date

Feb 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

No

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Mar 27, 2006

First Submission Date that Met QC Criteria

Mar 27, 2006

First Posted Date

Mar 29, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2012

Last Update Posted Date

Feb 13, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Sanwa Kagaku Kenkyusho Co., Ltd.INDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

This study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone for the treatment of macular edema associated with branch retinal vein occlusion.

Detailed Description

Not provided

Conditions Module

Conditions

Macular Degeneration
Macular Edema
Branch Retinal Vein Occlusion

Keywords

eye diseases

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
dexamethasone	Drug

Outcomes Module

No data available

No data is available for this block.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Macular edema resulting from branch retinal vein condition
The criteria for visual acuity and macular thickness are met

Exclusion Criteria:

History of glaucoma
Diabetic retinopathy
Known steroid-responder
Use of systemic steroids
Use of Warfarin/Heparin

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Study Group, Clinical Development Dept.	Sanwa Kagaku Kenkyusho Co., Ltd.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Aichi			Japan

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

Non-Randomized

Intervention Model

Single Group Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

None (Open Label)

Masking Description

Not provided

Who Masked

Not provided

Chiba

Japan

Fukuoka

Japan

Gunma

Japan

Hokkaido

Japan

Kagawa

Japan

Kyoto

Japan

Mie

Japan

Miyazaki

Japan

Osaka

Japan

Shiga

Japan

Tokyo

Japan

ID	Term
D008268	Macular Degeneration
D008269	Macular Edema
D012170	Retinal Vein Occlusion
D005128	Eye Diseases

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D020246	Venous Thrombosis
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated

Browse Leaves

Not provided

Browse Branches

Not provided