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

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ClinicalTrials.gov Identifier: NCT00712491
Recruitment Status : Terminated
First Posted : July 10, 2008
Last Update Posted : January 10, 2013
Sponsor:
Collaborator:
MacuSight, Inc.
Information provided by (Responsible Party):
Santen Inc.

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.

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Choroidal Neovascularization Drug: Sirolimus Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2010


Arm Intervention/treatment
Experimental: 1 Drug: Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
Other Name: MS-R002, rapamycin
Experimental: 2 Drug: Sirolimus
Three intravitreal injections of 352 micrograms sirolimus each.
Other Name: MS-R001, rapamycin



Primary Outcome Measures :
  1. Best-corrected visual acuity by ETDRS [ Time Frame: 180 days ]

Secondary Outcome Measures :
  1. Best-corrected visual acuity by ETDRS [ Time Frame: 60 days, 120 days ]
  2. Safety across injection routes [ Time Frame: Through 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00712491


Locations
United States, Arizona
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85044
Sponsors and Collaborators
Santen Inc.
MacuSight, Inc.
Investigators
Study Director: Joel Naor, MD MacuSight, Inc.

Responsible Party: Santen Inc.
ClinicalTrials.gov Identifier: NCT00712491     History of Changes
Other Study ID Numbers: AMD-002
First Posted: July 10, 2008    Key Record Dates
Last Update Posted: January 10, 2013
Last Verified: July 2010

Keywords provided by Santen Inc.:
wet AMD
CNV

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Sirolimus
Everolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs