Diabetic Macular Edema
Conditions
Keywords
diabetic macular edema, DME
Brief summary
The investigators hypothesize that a combination treatment with Avastin and Ozurdex will result in a more rapid improvement of visual acuity compared to the use of Avastin alone.
Interventions
DRUGBevacizumab
intravitreal, 1.25mg., monthly
DRUGdexamethasone intravitreal implant
0.7mg, intravitreal every 4 months
Sponsors
Maturi, Raj K., M.D., P.C.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female age 18 years or older * Type 1 or type 2 diabetes * BCVA score of \>24 and \<78 letters * Presence of DME defined as Optical Coherence Tomography Center Subfield Thickness (OCT CST) \>250microns
Exclusion criteria
* Anti-VEGF intravitreal treatment in last 4 weeks * Intravitreal steroid treatment in the last 8 weeks * PRP or Focal laser in last 4 months * Active iris neovascularization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | baseline to 12 month | Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best. |
| OCT CST | change in OCT CST from baseline to twelve months | change in optical coherence tomography central subfield thickness |
Countries
United States
Participant flow
Recruitment details
The study was conducted at a single center. The sample size was 40 eyes (30 subjects, 10 subjects had both eyes in study)
Pre-assignment details
Subjects were randomly assigned to either bevacizumab alone or bevacizumab plus Ozurdex in a 1:1 ratio. When both eyes were eligible, the right eye was randomized and the left eye was assigned to the other group. We had a total of 30 subjects, 10 with both eyes. 19 eyes were in the Bevacizumab Alone group and 21 eyes were in the Combined Group.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab Alone Bevacizumab only | 19 |
| Combine Group Bevacizumab plus Ozurdex | 21 |
| Total | 40 |
Baseline characteristics
| Characteristic | Bevacizumab Alone | Combine Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 14 Participants | 16 Participants | 30 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 5 Participants | 10 Participants |
| Age, Continuous | 62 years STANDARD_DEVIATION 9 | 59 years STANDARD_DEVIATION 12 | 60.5 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 19 eyes | 21 eyes | 40 eyes |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 10 Participants | 11 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 9 | 21 / 21 |
| serious Total, serious adverse events | 2 / 9 | 8 / 21 |
Outcome results
Primary
Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline
Visual Acuity was measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity test. Unit of measure is based on the ETDRS letter score scale, 0-97, where 0 = worst and 97 = best.
Time frame: baseline to 12 month
Population: The unit of measure is EYES rather than actual number of participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab Alone | Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | 4.9 letters | Standard Deviation 12.3 |
| Combined Group | Change in Best Corrected Visual Acuity (BCVA) Measured Using Early Treatment of Diabetic Retinopathy Study (ETDRS) Methodology at Month 12 Compared to Baseline | 5.4 letters | Standard Deviation 10.7 |
Primary
OCT CST
change in optical coherence tomography central subfield thickness
Time frame: change in OCT CST from baseline to twelve months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab Alone | OCT CST | 30 microns | Standard Deviation 100 |
| Combined Group | OCT CST | 45 microns | Standard Deviation 107 |