Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis

Vitreo-Retinal Associates, Michigan10 enrolled

Overview

The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.

Lucentis injections are the current standard of care for diabetic macular edema. The only deviation from the standard of care in the current protocol is an aqueous tap before the first Lucentis injection and the fourth Lucentis injection for diabetic macular edema.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Diabetic Macular Edema

Interventions

LucentisDRUG

0.3mg Lucentis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of diabetes mellitus * Best corrected visual acuity 20/32 - 20/320 * Diabetic macular edema involving the center of the macula * Optical coherence tomography central subfield thickness of at least 250 microns Exclusion Criteria: * History of anti-vascular endothelial growth factor treatment in the past 12 months * Any diabetic macular edema treatment in the past 4 months * Heart attack, stroke, transient ischemic attack or acute congestive heart failure within 4 months

Locations (1)

Vitreo-Retinal Associates

Grand Rapids, Michigan, United States

Outcomes

Primary Outcomes

Vascular Endothelial Growth Factor Levels

An aqueous humor specimen was obtained at baseline and at 12 weeks to determine if the levels of VEGF had decreased with treatment.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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