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The Ranibizumab for Edema of the mAcula in Diabetes-2 (READ-2) Study

NCT00407381 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2017-03-31

Study results available
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Summary

This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME.

RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.

Conditions

Interventions

DRUG

Ranibizumab

Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.

PROCEDURE

Laser photocoagulation

Laser photocoagulation in either focal or grid pattern as determined by investigator.

Sponsors & Collaborators

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • Genentech, Inc.

    collaborator INDUSTRY

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Diana Do, MD · Truhlsen Eye Institute, University of Nebraska Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00407381 on ClinicalTrials.gov