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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-19

Study Completion Date

2018-02-02

Brief Summary

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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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Detailed Description

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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.

Conditions

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Diabetic Macular Edema

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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0.3 mg Lucentis

Aqueous Humor sample post injection of 0.3 mg Lucentis

Group Type EXPERIMENTAL

Lucentis

Intervention Type DRUG

0.3mg Lucentis

Interventions

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Lucentis

0.3mg Lucentis

Intervention Type DRUG

Other Intervention Names

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Aqueous Tap

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No