NCT00712491

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 8, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

January 10, 2013

Status Verified

July 1, 2010

Enrollment Period

1.2 years

First QC Date

July 8, 2008

Last Update Submit

January 8, 2013

Conditions

Age-related Macular DegenerationChoroidal Neovascularization

Keywords

wet AMDCNV

Outcome Measures

Primary Outcomes (1)

  • Best-corrected visual acuity by ETDRS

    180 days

Secondary Outcomes (2)

  • Best-corrected visual acuity by ETDRS

    60 days, 120 days

  • Safety across injection routes

    Through 1 year

Study Arms (2)

1

EXPERIMENTAL
Drug: Sirolimus

2

EXPERIMENTAL
Drug: Sirolimus

Interventions

SirolimusDRUG

Three subconjunctival injections of 1320 micrograms sirolimus each.

Also known as: MS-R002, rapamycin
1

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Retinal Consultants of Arizona

Phoenix, Arizona, 85044, United States

Location

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

Sirolimus

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Joel Naor, MD

    MacuSight, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2008

First Posted

July 10, 2008

Study Start

September 1, 2008

Primary Completion

November 1, 2009

Study Completion

March 1, 2010

Last Updated

January 10, 2013

Record last verified: 2010-07

Locations

US(1)