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Laser-Ranibizumab-Triamcinolone for Proliferative Diabetic Retinopathy

NCT00445003 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2016-08-26

Study results available
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Summary

The purpose of the study is to find out if treatment with an intravitreal injection of triamcinolone or an intravitreal injection of ranibizumab can prevent loss of vision caused by panretinal photocoagulation treatment. At the present time, it is not known whether intravitreal steroid or anti-vascular endothelial growth factor (anti-VEGF) injections are beneficial in preventing vision loss after panretinal photocoagulation (PRP) treatment. It is possible that one or both of the types of injections will prevent vision loss after PRP treatment. However, it is not known whether the benefits of the injections will outweigh the risks. It is possible that because of side effects, the injections may not be as good as laser alone in treating the diabetic retinopathy.

Conditions

Interventions

DRUG

Ranibizumab

Intravitreal injection of 0.5 mg ranibizumab at baseline and 4 weeks

DRUG

Triamcinolone Acetonide

Intravitreal injection of 4 mg triamcinolone acetonide at baseline and sham injection at 4 weeks

BEHAVIORAL

Sham injection

Sham injection at baseline and 4 weeks

PROCEDURE

Focal/grid laser

Focal/grid laser for diabetic macular edema was performed 3 days to 10 days after the injection for all treatment groups.

Sponsors & Collaborators

  • National Eye Institute (NEI)

    collaborator NIH

  • Genentech, Inc.

    collaborator INDUSTRY

  • Allergan

    collaborator INDUSTRY

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Alexander J. Brucker, M.D. · Scheie Eye Institute

  • Joseph Googe, Jr., M.D. · Southeastern Retina Associates, P.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2009-10-31
Completion
2010-07-31

Countries

  • United States

Study Locations

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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 NCT00445003 on ClinicalTrials.gov