Diabetic Macular Edema
Conditions
Brief summary
To determine if there is visual benefit with Ozurdex treatment every three months compared to monthly anti-VEGF alone, in subjects with persistent diabetic macular edema. The investigator hypothesizes more frequent administration of Ozurdex in patients that have persistent diabetic macular edema will result in a more rapid and sustained improvement of visual acuity and/or optical coherence topography (OCT) compared to the use of anti-VEGF alone.
Detailed description
Statistics throughout this study referred to the number of eyes rather than the number of subjects. Subjects were allowed to have both eyes in the study provided that inclusion/exclusion criteria were met. Five subjects had both eyes in the study; 45 subjects were actually enrolled, resulting in 50 study eyes.
Interventions
DRUGOzurdex
intravitreal steroid
DRUGBevacizumab
antiVEGF
Sponsors
Allergan
Raj K. Maturi, MD
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
1. Male of female age 18 years or older 2. Type 1 or Type 2 diabetes 3. Best corrected visual acuity (BCVA) score of \>24 and \<78 letters 4. History of at least 3 anti-VEGF intravitreal injections over the past 5 months 5. Presence of macular edema defined as central subfield thickness of \>340 microns on Cirrus OCT
Exclusion criteria
1. Anti-VEGF intravitreal treatment in the last 4 weeks 2. Intravitreal steroid treatment in the last 8 weeks or Ozurdex in the last 4 months 3. Pan retinal photocoagulation (PRP) or focal laser in the last 4 months 4. Active iris neovascularization 5. Any ocular condition in the study eye that, in the opinion of the investigator, is severe enough to compromise the study result 6. Uncontrolled systemic disease 7. Known history of intraocular pressure (IOP) elevation in response to corticosteroid treatment, that is not controlled on 2 glaucoma medications 8. Current enrollment in an investigational drug study or participation in such a study within 30 days prior to the baseline visit 9. Female patients who are pregnant, nursing or planning a pregnancy or who are of childbearing potential and not using a reliable means of contraception 10. Any condition or reason (including inability to read early treatment diabetic retinopathy study (ETDRS) chart or language barrier) that precludes the patient's ability to comply with study requirements including completion of the study 11. Patients with active or suspected ocular or periocular infections including most viral diseases of the cornea and conjunctiva, including active epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial infections, and fungal diseases. 12. Aphakia or pseudophakia with anterior chamber intraocular lens 13. Hypersensitivity to any components of Ozurdex or Avastin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Visual Acuity Change | baseline to month 7 | Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change. |
| Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | baseline to month seven | Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from the PI's clinical practice from January 2014 through October 2014.
Pre-assignment details
This trial had 50 study eyes from a total of 45 participants. 5 participants had both eyes in the study.
Participants by arm
| Arm | Count |
|---|---|
| Bevacizumab 1.25 mg intravitreal injection given monthly during a 6 month period
Bevacizumab: antiVEGF | 23 |
| Ozurdex Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections
Ozurdex: intravitreal steroid | 27 |
| Total | 50 |
Baseline characteristics
| Characteristic | Ozurdex | Bevacizumab | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 16 Participants | 9 Participants | 25 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 14 Participants | 25 Participants |
| Age, Continuous | 65 years STANDARD_DEVIATION 11 | 61 years STANDARD_DEVIATION 9 | 63 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 27 study eyes | 23 study eyes | 50 study eyes |
| Sex: Female, Male Female | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Male | 12 Participants | 13 Participants | 25 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 23 | 15 / 27 |
| serious Total, serious adverse events | 7 / 23 | 3 / 22 |
Outcome results
Primary
Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven
Optical coherence tomography (OCT) is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images. The image is presented in grid form which divides that retina into sections. The center most section (CST) is used for this outcome measurement.
Time frame: baseline to month seven
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab | Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | -13 microns | Standard Deviation 105 |
| Ozurdex | Change in Optical Coherence Tomography (OCT) Central Subfield Thickness (CST) From Baseline to Month Seven | -122 microns | Standard Deviation 120 |
Primary
Mean Visual Acuity Change
Visual acuity was obtained using ETDRS method and the total number of letters correct using that method was used to calculate mean visual acuity change.
Time frame: baseline to month 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bevacizumab | Mean Visual Acuity Change | 5.6 ETDRS letters | Standard Deviation 6.1 |
| Ozurdex | Mean Visual Acuity Change | 5.8 ETDRS letters | Standard Deviation 7.6 |