Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formul... | NCT00712491

Studies
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration

NCT00712491

Sponsor

Santen Inc.

Status

Terminated

Last Update Posted

Jan 10, 2013Estimated

Enrollment

20Actual

Phase

Phase 1Phase 2

Conditions

Age-related Macular Degeneration
Choroidal Neovascularization

Interventions

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

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Nov 2009Actual

Completion Date

Mar 2010Actual

First Submitted Date

Jul 8, 2008

First Submission Date that Met QC Criteria

Jul 8, 2008

First Posted Date

Jul 10, 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 via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

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 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental		Drug: Sirolimus
2	Experimental		Drug: Sirolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sirolimus	Drug	Three subconjunctival injections of 1320 micrograms sirolimus each.	1

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Best-corrected visual acuity by ETDRS		60 days, 120 days
Safety across injection routes		Through 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria include, but are not limited to:

Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration
Visual acuity of 20/50 to 20/200 in study eye

Exclusion Criteria:

Any other ocular disease that could compromise vision in the study eye
History of any prior treatment for choroidal neovascularization in the study eye
Presence of other causes of choroidal neovascularization other than secondary to age-related macular degeneration

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 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	85044	United States

Type	Date	Date Unknown
Release	Apr 27, 2017
Reset	May 31, 2017

Submission Tracking

Estimated Results First Submitted Date

Apr 27, 2017

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 27, 2017			May 31, 2017

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D020256	Choroidal Neovascularization

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases
D015862	Choroid 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