- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00766337
Phase 2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Combination With Lucentis® in Patients With Age-Related Macular Degeneration (EMERALD)
January 8, 2013 updated by: Santen Inc.
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
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.
Study Overview
Status
Terminated
Study Type
Interventional
Enrollment (Actual)
62
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Phoenix, Arizona, United States, 85014
- Retinal Consultants of Arizona
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dose Group 1
|
Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Names:
Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Names:
|
Experimental: Dose Group 2
|
Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Names:
Combination therapy of 1320 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Names:
|
Placebo Comparator: Dose Group 3
|
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Best-corrected visual acuity by ETDRS
Time Frame: 120 days
|
120 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Retinal thickness
Time Frame: 120 days
|
120 days
|
Safety across treatment groups
Time Frame: Through 2 years
|
Through 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
November 1, 2009
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
October 1, 2008
First Submitted That Met QC Criteria
October 1, 2008
First Posted (Estimate)
October 3, 2008
Study Record Updates
Last Update Posted (Estimate)
January 10, 2013
Last Update Submitted That Met QC Criteria
January 8, 2013
Last Verified
July 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Metaplasia
- Macular Degeneration
- Choroidal Neovascularization
- Neovascularization, Pathologic
- Physiological Effects of Drugs
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Ranibizumab
- Sirolimus
Other Study ID Numbers
- AMD-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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