MedTrace Logo

Dose Ranging Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Diabetic Macular Edema

NCT00656643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 131

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 at various doses in patients with diabetic macular edema.

Conditions

Interventions

DRUG

Sirolimus

Two subconjunctival injections of 440 micrograms sirolimus each.

DRUG

Placebo

Two subconjunctival injections of placebo.

DRUG

Sirolimus

Two subconjunctival injections of 220 micrograms sirolimus each.

DRUG

Sirolimus

Two subconjunctival injections of 880 micrograms sirolimus each.

Sponsors & Collaborators

  • MacuSight, Inc.

    collaborator INDUSTRY

  • Santen Inc.

    lead INDUSTRY

Principal Investigators

  • Joel Naor, MD · MacuSight, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-11-30
Completion
2012-05-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT00656643 on ClinicalTrials.gov