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OpenTrials
Completed

NCT Number: NCT03097068

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

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

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Key information

Conditions

Diabetic Macular Edema

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vitreo-Retinal Associates

Grand Rapids, Michigan, 49546, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Lucentis

Drug

0.3mg Lucentis

Other names: Aqueous Tap

Primary outcomes

  1. Vascular Endothelial Growth Factor Levels

    Time frame: 12 weeks

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

Sponsors and collaborators

Lead sponsor

Vitreo-Retinal Associates, Michigan

Other

Collaborators

  • Genentech, Inc.
  • Michigan State University

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Mar 31, 2017
Registry last updated
Oct 24, 2022

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.

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