Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration

December 16, 2014 updated by: Vitreo-Retinal Associates, Michigan
The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Grand Rapids, Michigan, United States, 49525
        • Vitreo-Retinal Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female age 18 to 85 with diabetes and hemoglobin A1C </= 10, or exudative macular degeneration.
  • Diabetic macular edema with average retinal thickness central subfield >/= 290um.

Exclusion Criteria:

  • Macular atrophy/fibrosis.
  • Ocular anti-VEGF treatment within 3 months.
  • Treatment with topical or oral carbonic-anhydrase inhibitor within one month
  • Laser photocoagulation within 3 months (diabetic cohort)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Avastin for Diabetic Macular Edema
1.25 mg avastin monthly for 4 months
Drug: Avastin
1.25 mg monthly for 4 months
Active Comparator: Avastin for Exudative Macular Degeneration
1.25 mg Avastin monthly for 4 months
Drug: Avastin
1.25 mg monthly for 4 months
Active Comparator: Lucentis for Exudative Macular Degeneration
0.5 mg Lucentis monthly for 4 months
Drug: Lucentis
0.5 mg monthly for 4 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of collected vitreous samples to identify biomarkers.
Time Frame: End of study
Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vitreo-Retinal Associates, Michigan

Collaborators

Van Andel Research Institute

Investigators

  • Principal Investigator: Louis C. Glazer, MD, Vitreo Retinal Associates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

November 14, 2011

First Submitted That Met QC Criteria

November 14, 2011

First Posted (Estimate)

November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 17, 2014

Last Update Submitted That Met QC Criteria

December 16, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VARI 2011 002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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