Back to resultsAnalysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Primary Purpose
Diabetic Macular Edema
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lucentis
Sponsored by
About this trial
This is an interventional basic science trial for Diabetic Macular Edema
Eligibility Criteria
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
Sites / Locations
- Vitreo-Retinal Associates
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
0.3 mg Lucentis
Arm Description
Aqueous Humor sample post injection of 0.3 mg Lucentis
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03097068
First Posted
March 21, 2017
Last Updated
October 21, 2022
Sponsor
Vitreo-Retinal Associates, Michigan
Collaborators
Genentech, Inc., Michigan State University
1. Study Identification
Unique Protocol Identification Number
NCT03097068
Brief Title
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Official Title
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 19, 2017 (Actual)
Primary Completion Date
December 6, 2017 (Actual)
Study Completion Date
February 2, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vitreo-Retinal Associates, Michigan
Collaborators
Genentech, Inc., Michigan State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The protocol will measure a number of cytokines in addition to vascular endothelial growth factor in response to 0.3mg Lucentis.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.3 mg Lucentis
Arm Type
Experimental
Arm Description
Aqueous Humor sample post injection of 0.3 mg Lucentis
Intervention Type
Drug
Intervention Name(s)
Lucentis
Other Intervention Name(s)
Aqueous Tap
Intervention Description
0.3mg Lucentis
Primary Outcome Measure Information:
Title
Vascular Endothelial Growth Factor Levels
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Vitreo-Retinal Associates
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Analysis of Cytokines in Response to Treatment of Diabetic Macular Edema With 0.3mg Lucentis
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