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

Age-Related Macular Degeneration Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00766337
• Other study ID #: AMD-003
• Status: Terminated
• Phase: Phase 2
• First received: October 1, 2008
• Last updated: January 8, 2013
• Start date: December 2008
• Est. completion date: March 2010

Study information

• Verified date: July 2010
• Source: Santen Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 62
• Est. completion date: March 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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.
• 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.
• Placebo in combination with ranibizumab
Combination therapy of placebo injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.

Locations

Country	Name	City	State
United States	Retinal Consultants of Arizona	Phoenix	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Santen Inc.	MacuSight, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best-corrected visual acuity by ETDRS		120 days
Secondary	Retinal thickness		120 days
Secondary	Safety across treatment groups		Through 2 years