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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Santen Inc.
Study ID
NCT00766337
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 3, 2008
Start date
Dec 31, 2008
Status verified
Jul 2010
Primary completion
Nov 30, 2009
Completion
Mar 31, 2010

Study Design

Enrollment
62 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Group 1
  • Experimental: Dose Group 2
  • Placebo Comparator: Dose Group 3

Primary Outcome Measure

Best-corrected visual acuity by ETDRS [ Time Frame: 120 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retinal Consultants of ArizonaPhoenixArizona85014-

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
Retinal Consultants of Arizona· Phoenix, AZ

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