MedTrace Logo

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

NCT00766337 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2013-01-10

No results posted yet for this study

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.

Conditions

  • Age-Related Macular Degeneration
  • Choroidal Neovascularization

Interventions

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.

DRUG

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.

DRUG

Placebo in combination with ranibizumab

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

Sponsors & Collaborators

  • MacuSight, Inc.

    collaborator INDUSTRY

  • Santen Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Naor, MD · MacuSight, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2009-11-30
Completion
2010-03-31

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00766337 on ClinicalTrials.gov