Back to resultsPhase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration (EMERALD)
Primary Purpose
Age-Related Macular Degeneration, Choroidal Neovascularization
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sirolimus in combination with ranibizumab
Sirolimus in combination with ranibizumab
Placebo in combination with ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring wet AMD
Eligibility 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
Sites / Locations
- Retinal Consultants of Arizona
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Dose Group 1
Dose Group 2
Dose Group 3
Arm Description
Outcomes
Primary Outcome Measures
Best-corrected visual acuity by ETDRS
Secondary Outcome Measures
Retinal thickness
Safety across treatment groups
Full Information
NCT ID
NCT00766337
First Posted
October 1, 2008
Last Updated
January 8, 2013
Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00766337
Brief Title
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
Acronym
EMERALD
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 Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Terminated
Study Start Date
December 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Santen Inc.
Collaborators
MacuSight, Inc.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration, Choroidal Neovascularization
Keywords
wet AMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dose Group 1
Arm Type
Experimental
Arm Title
Dose Group 2
Arm Type
Experimental
Arm Title
Dose Group 3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sirolimus in combination with ranibizumab
Other Intervention Name(s)
MS-R001, rapamycin, Lucentis
Intervention Description
Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Intervention Type
Drug
Intervention Name(s)
Sirolimus in combination with ranibizumab
Other Intervention Name(s)
MS-R002, rapamycin, Lucentis
Intervention Description
Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Intervention Type
Drug
Intervention Name(s)
Placebo in combination with ranibizumab
Other Intervention Name(s)
vehicle, Lucentis
Intervention Description
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Primary Outcome Measure Information:
Title
Best-corrected visual acuity by ETDRS
Time Frame
120 days
Secondary Outcome Measure Information:
Title
Retinal thickness
Time Frame
120 days
Title
Safety across treatment groups
Time Frame
Through 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joel Naor, MD
Organizational Affiliation
MacuSight, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration
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