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

Santen

Status and phase

Terminated

Phase 2

Conditions

Choroidal Neovascularization

Age-Related Macular Degeneration

Treatments

Drug: Sirolimus in combination with ranibizumab

Drug: Placebo in combination with ranibizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT00766337

AMD-003

Details and patient eligibility

About

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.

Enrollment

62 patients

Sex

All

Ages

50+ years old

Volunteers

No 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