Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration - Full Text View

Sponsored by:	MacuSight, Inc.
Information provided by:	MacuSight, Inc.
ClinicalTrials.gov Identifier:	NCT00766337

Purpose

The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation in combination with Lucentis in patients with sub-foveal choroidal neovascularization secondary to age-related macular degeneration.

Condition	Intervention	Phase
Age-Related Macular Degeneration Choroidal Neovascularization	Drug: Sirolimus in combination with ranibizumab Drug: Placebo in combination with ranibizumab	Phase II

Genetics Home Reference related topics: X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab Sirolimus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Phase 2, Randomized, Masked, Controlled Clinical Study to Assess the Safety and Efficacy of Lucentis® Plus Sirolimus Versus Lucentis® Plus Placebo in Patients With Sub-Foveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Further study details as provided by MacuSight, Inc.:

Primary Outcome Measures:

Best-corrected visual acuity by ETDRS [ Time Frame: 120 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Retinal thickness [ Time Frame: 120 days ] [ Designated as safety issue: No ]
Safety across treatment groups [ Time Frame: Through 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Dose Group 1: Experimental	Drug: Sirolimus in combination with ranibizumab Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Dose Group 2: Experimental	Drug: Sirolimus in combination with ranibizumab Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Dose Group 3: Placebo Comparator	Drug: Placebo in combination with ranibizumab Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosed with sub-foveal choroidal neovascularization secondary to age-related macular degeneration within six months of initial study visit, and may have been treated with up to 3 Lucentis® (ranibizumab) or 3 Avastin® (bevacizumab) injections with the last injection administered at least 4 weeks prior to the initial study visit, or is treatment-naïve
Visual acuity of 20/40 to 20/200 in the study eye

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00766337

Contacts

Contact: Celine Delpouys

510-400-1440

cdelpouys@macusight.com

Locations

United States, Arizona
Retinal Consultants of Arizona	Recruiting
Phoenix, Arizona, United States, 85014
Contact: Elena Baj 602-222-2221 ext 131 ebaj@retinalconsultantsaz.com
Principal Investigator: Derek Kunimoto, MD

Sponsors and Collaborators

MacuSight, Inc.

Investigators

Study Director:

Joel Naor, MD

MacuSight, Inc.

More Information

Responsible Party:	MacuSight ( Kathy Jensen/Director of Clinical Operations )
Study ID Numbers:	AMD-003
Study First Received:	October 1, 2008
Last Updated:	December 12, 2008
ClinicalTrials.gov Identifier:	NCT00766337
Health Authority:	United States: Food and Drug Administration

Keywords provided by MacuSight, Inc.:

wet AMD

Study placed in the following topic categories:

Sirolimus
Clotrimazole
Eye Diseases
Miconazole
Choroid Diseases
Tioconazole
Macular Degeneration

Retinal Degeneration
Choroidal Neovascularization
Metaplasia
Neoplasm Metastasis
Neovascularization, Pathologic
Retinal Diseases
Retinal degeneration

Additional relevant MeSH terms:

Anti-Bacterial Agents
Anti-Infective Agents
Uveal Diseases
Pathologic Processes
Immunologic Factors
Antineoplastic Agents

Antifungal Agents
Therapeutic Uses
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009