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

Diabetic Macular Edema Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03097068
• Other study ID #: ML39638
• Status: Completed
• Phase: Phase 4
• Start date: April 19, 2017
• Est. completion date: February 2, 2018

Study information

• Verified date: October 2022
• Source: Vitreo-Retinal Associates, Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2, 2018
• Est. primary completion date: December 6, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Lucentis
0.3mg Lucentis

Locations

Country	Name	City	State
United States	Vitreo-Retinal Associates	Grand Rapids	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
Vitreo-Retinal Associates, Michigan	Genentech, Inc., Michigan State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks