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: Sirolimus Ranibizumab

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

No publications provided

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 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by MacuSight, Inc.:

wet AMD

Study placed in the following topic categories:

Sirolimus
Immunologic Factors
Clotrimazole
Miconazole
Eye Diseases
Choroid Diseases
Tioconazole
Macular Degeneration
Retinal Degeneration

Immunosuppressive Agents
Choroidal Neovascularization
Anti-Bacterial Agents
Metaplasia
Antifungal Agents
Neoplasm Metastasis
Neovascularization, Pathologic
Retinal Diseases

Additional relevant MeSH terms:

Sirolimus
Anti-Infective Agents
Uveal Diseases
Immunologic Factors
Antineoplastic Agents
Eye Diseases
Physiological Effects of Drugs
Choroid Diseases
Macular Degeneration
Retinal Degeneration
Antibiotics, Antineoplastic

Immunosuppressive Agents
Pharmacologic Actions
Choroidal Neovascularization
Anti-Bacterial Agents
Pathologic Processes
Antifungal Agents
Therapeutic Uses
Metaplasia
Neovascularization, Pathologic
Retinal Diseases

ClinicalTrials.gov processed this record on May 07, 2009