Diabetic Macular Edema
Conditions
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.
Interventions
DRUGLucentis
0.3mg Lucentis
Sponsors
Genentech, Inc.
Michigan State University
Vitreo-Retinal Associates, Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vascular Endothelial Growth Factor Levels | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 0.3 mg Lucentis Aqueous Humor sample post injection of 0.3 mg Lucentis
Lucentis: 0.3mg Lucentis | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | 0.3 mg Lucentis |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants |
| OCT Central Subfield Thickness | 518.1 microns STANDARD_DEVIATION 257.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| 0.3 mg Lucentis | Vascular Endothelial Growth Factor Levels | 73.46 pg/ml |