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

Sponsor

Santen Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT00766337

Collaborator

MacuSight, Inc. (Industry)

Enrollment

Location

Arms

14.9

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration Choroidal Neovascularization	Drug: Sirolimus in combination with ranibizumab Drug: Sirolimus in combination with ranibizumab Drug: Placebo in combination with ranibizumab	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

62 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Dec 1, 2008

Actual Primary Completion Date :

Nov 1, 2009

Actual Study Completion Date :

Mar 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose Group 1	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. Other Names: MS-R001 rapamycin Lucentis
Experimental: Dose Group 2	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. Other Names: MS-R002 rapamycin Lucentis
Placebo Comparator: Dose Group 3	Drug: Placebo in combination with ranibizumab Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period. Other Names: vehicle Lucentis

Arm

Intervention/Treatment

Experimental: Dose Group 1

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.

Other Names:

MS-R001

rapamycin

Lucentis

Experimental: Dose Group 2

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.

Other Names:

MS-R002

rapamycin

Lucentis

Placebo Comparator: Dose Group 3

Drug: Placebo in combination with ranibizumab

Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.

Other Names:

vehicle

Lucentis

Outcome Measures

Primary Outcome Measures

Best-corrected visual acuity by ETDRS [120 days]

Secondary Outcome Measures

Retinal thickness [120 days]
Safety across treatment groups [Through 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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