Safety and Tolerability of MS-R001 in Patients With Diabetic Macular Edema Secondary to Diabetic Retinopathy

NCT00401115 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2010-07-26

No results posted yet for this study

Summary

The purpose of this study is to determine the safety and tolerability of MS-R001 at escalating doses in patients with diabetic macular edema secondary to diabetic retinopathy

Conditions

Interventions

DRUG

MS-R001 (rapamycin)

Subconjunctival injection in various dosages

DRUG

MS-R001 (rapamycin)

Intraocular injection in various dosages

Sponsors & Collaborators

  • MacuSight, Inc.

    collaborator INDUSTRY
  • Santen Inc.

    lead INDUSTRY

Principal Investigators

  • Pravin Dugel, M.D. · Retina Consultants of Arizona

  • Wayne Solley, M.D. · Texas Retina Associates

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

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Entities

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 NCT00401115 on ClinicalTrials.gov