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

Primary Purpose

Age-related Macular Degeneration, Choroidal Neovascularization

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sirolimus
Sirolimus
Sponsored by
Santen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring wet AMD, CNV

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Retinal Consultants of Arizona

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Best-corrected visual acuity by ETDRS

Secondary Outcome Measures

Best-corrected visual acuity by ETDRS
Safety across injection routes

Full Information

First Posted
July 8, 2008
Last Updated
January 8, 2013
Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00712491
Brief Title
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
Official Title
A Phase 1/2, Randomized Clinical Study to Assess the Safety and Efficacy of Sirolimus in Patients With Newly Diagnosed, Treatment-Naive Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration, Choroidal Neovascularization
Keywords
wet AMD, CNV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
MS-R002, rapamycin
Intervention Description
Three subconjunctival injections of 1320 micrograms sirolimus each.
Intervention Type
Drug
Intervention Name(s)
Sirolimus
Other Intervention Name(s)
MS-R001, rapamycin
Intervention Description
Three intravitreal injections of 352 micrograms sirolimus each.
Primary Outcome Measure Information:
Title
Best-corrected visual acuity by ETDRS
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Best-corrected visual acuity by ETDRS
Time Frame
60 days, 120 days
Title
Safety across injection routes
Time Frame
Through 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Naor, MD
Organizational Affiliation
MacuSight, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85044
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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