A Phase 1/2 interventional study of Sirolimus and Sirolimus in Age-related Macular Degeneration and Choroidal Neovascularization, sponsored by Santen Inc.. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2013-01-10.
Sponsored by Santen Inc. · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety and efficacy of an ocular sirolimus (rapamycin) formulation via different injection routes in patients with treatment-naive sub-foveal choroidal neovascularization secondary to age-related macular degeneration.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 20 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Santen Inc. is the lead sponsor of 31 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria include, but are not limited to:
Exclusion Criteria:
Drug: Sirolimus
Drug: Sirolimus
Three subconjunctival injections of 1320 micrograms sirolimus each.
Also known as: MS-R002, rapamycin
Three intravitreal injections of 352 micrograms sirolimus each.
Also known as: MS-R001, rapamycin
Best-corrected visual acuity by ETDRS
Time frame: 180 days
Best-corrected visual acuity by ETDRS
Time frame: 60 days, 120 days
Safety across injection routes
Time frame: Through 1 year
This study is terminated, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Santen Inc.