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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00766337

Acronym

EMERALD

Enrollment

Registered

2008-10-03

Start date

2008-12-31

Completion date

2010-03-31

Last updated

2013-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration, Choroidal Neovascularization

Keywords

wet AMD

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.

Interventions

DRUGSirolimus in combination with ranibizumab

Combination therapy of 440 micrograms sirolimus injected subconjunctivally and 500 micrograms ranibizumab injected intravitreally over a 60 day treatment period.

DRUGPlacebo in combination with ranibizumab

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Best-corrected visual acuity by ETDRS	120 days

Secondary

Measure	Time frame
Retinal thickness	120 days
Safety across treatment groups	Through 2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026