Safety and Tolerability of MS-R001 in Patients With Diabe... | NCT00401115

Studies
Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

NCT00401115

Sponsor

Santen Inc.

Status

Completed

Last Update Posted

Jul 26, 2010Estimated

Enrollment

50Actual

Phase

Phase 1

Conditions

Diabetic Macular Edema
Diabetic Retinopathy

Interventions

MS-R001 (rapamycin)
MS-R001 (rapamycin)

Countries

United States

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

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

Status Module

Record Verification Date

Jul 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jun 2008Actual

Completion Date

Jun 2008Actual

First Submitted Date

Nov 15, 2006

First Submission Date that Met QC Criteria

Nov 15, 2006

First Posted Date

Nov 17, 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

Jul 22, 2010

Last Update Posted Date

Jul 26, 2010Estimated

Name	Class
MacuSight, Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Detailed Description

Not provided

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 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Subconjunctival injection	Drug: MS-R001 (rapamycin)
2	Experimental	Intraocular injection	Drug: MS-R001 (rapamycin)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MS-R001 (rapamycin)	Drug	Subconjunctival injection in various dosages	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability as assessed by visual acuity, intraocular pressure, slit lamp and indirect ophthalmoscope		12 months

Secondary Outcomes

Measure	Description	Time Frame
Visual Acuity		90 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria include but are not limited to:

Diagnosed with diabetes mellitus
Visual acuity of 20/40 to 20/200 in study eye

Exclusion Criteria include but are not limited to:

Any other ocular disease that could compromise vision in the study eye
Intraocular surgery of the study eye within 90 days prior to study start
Capsulotomy of the study eye within 30 days prior to study start

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pravin Dugel, M.D.	Retina Consultants of Arizona	Principal Investigator
Wayne Solley, M.D.	Texas Retina Associates	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retina Consultants of Arizona		Phoenix	Arizona	85014	United States
Texas Retina Associates

Condition Browse Module

MeSH Terms

ID	Term
D003930	Diabetic Retinopathy

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D003925	Diabetic Angiopathies
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020123	Sirolimus

Ancestor Terms

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided