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

The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.

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Key information

Conditions

Exudative Macular Degeneration Diabetic Macular Edema Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases Wet Macular Degeneration

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49525, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Avastin

Drug

1.25 mg monthly for 4 months

Lucentis

Drug

0.5 mg monthly for 4 months

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Vitreo-Retinal Associates, Michigan

Other

Collaborators

Van Andel Research Institute

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 17, 2011
Registry last updated: Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed