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

Vitreo-Retinal Associates, Michigan

Status and phase: Completed; Phase 4

Conditions: Diabetic Macular Edema

Treatments: Drug: Lucentis

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03097068

ML39638

Details and patient eligibility

About

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

Full description

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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

0.3 mg Lucentis

Experimental group

Description:

Aqueous Humor sample post injection of 0.3 mg Lucentis

Treatment:

Drug: Lucentis