Dose Ranging Study of an Ocular Sirolimus (Rapamycin) For... | NCT00656643

Studies
Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

NCT00656643

Sponsor

Santen Inc.

Status

Completed

Last Update Posted

Jan 10, 2013Estimated

Enrollment

131Actual

Phase

Phase 2

Conditions

Diabetic Macular Edema

Interventions

Sirolimus
Placebo
Sirolimus
Sirolimus

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

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

Jun 2008

Primary Completion Date

Nov 2009Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 4, 2008

First Submission Date that Met QC Criteria

Apr 4, 2008

First Posted Date

Apr 11, 2008Estimated

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

Jan 8, 2013

Last Update Posted Date

Jan 10, 2013Estimated

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 efficacy of an ocular sirolimus (rapamycin) formulation at various doses in patients with diabetic macular edema.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

131Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
1	Experimental	Drug: Sirolimus
2	Experimental	Drug: Sirolimus
3	Experimental	Drug: Sirolimus
4	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus	Drug	Two subconjunctival injections of 440 micrograms sirolimus each.	2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Best-corrected visual acuity by ETDRS		180 days

Secondary Outcomes

Measure	Description	Time Frame
Foveal central subfield thickness as determined by OCT		180 days
Safety across dose groups versus placebo		180 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria include but are not limited to:

Diagnosed with diabetes mellitus
Macular edema secondary to diabetic retinopathy
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
Any of the following treatments to the study eye within 90 days prior to study start: intravitreal injections; posterior subtenons steroids; focal/grid macular photocoagulation; intraocular surgery
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
Joel Naor, MD	MacuSight, Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Retinal Consultants of Arizona		Phoenix	Arizona	85014	United States

Type	Date	Date Unknown
Release	May 2, 2017
Reset	May 31, 2017

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
May 2, 2017			May 31, 2017

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