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

Vitreo-Retinal Associates, Michigan16 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Exudative Macular Degeneration Diabetic Macular Edema

Interventions

AvastinDRUG

1.25 mg monthly for 4 months

AvastinDRUG

1.25 mg monthly for 4 months

LucentisDRUG

0.5 mg monthly for 4 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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)

Locations (1)

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

Analysis of collected vitreous samples to identify biomarkers.

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.

Time frame: End of study

Data from ClinicalTrials.gov

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