Diabetic Macular Edema
Conditions
Keywords
Diabetic Macular Edema, DME, Pars Plana Vitrectomy
Brief summary
Currently medications injected intravitreally in previously vitrectomized eyes have a very short half-life due to enhanced clearance of the drug. The use of the Ozurdex (dexamethasone) implant may allow sustained levels of steroid delivery to patients with diabetic macular edema that have undergone prior vitrectomy. The sustained steroid levels may lead to improved central retinal thickness measurements and improved visual acuity.
Detailed description
A total of 15 patients will be enrolled into the study. This is a 3 year randomized controlled study with the primary endpoint at 1 year. Secondary safety and efficacy endpoints will be evaluated in year 2 and year 3. Patients will be randomly enrolled into 1 of 3 groups: Group 1: Dexamethasone administered up to every 3 months Group 2: Dexamethasone administered up to every 6 months Group 3: Sham Patients will be evaluated on a monthly basis with ETDRS visual acuity, intraocular pressure, fundus examination and OCT. Ozurdex (dexamethasone) or Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter. One month following initial injection/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Re-implantation of Ozurdex may occur at any time \> 3 months following last injection in group 1 and \> 6 months following last injection in group 2 if any of the following conditions are met: 1. Increase of \> 50 microns from the best previous CRT measurement 2. Recurrence of intraretinal cystic edema 3. Persistent intraretinal cystic edema At 13 months, patients in the sham group will be eligible for Ozurdex implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2 (up to every 6 months).
Interventions
DRUGDexamethasone
Ozurdex (dexamethasone) 0.7mg steroid implant
Sponsors
Lahey Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adults\> 18 years of age with type 1 or 2 diabetes mellitus 2. Patients with DME secondary to diabetes mellitus involving the center of the macula OCT thickness is \> 300 microns with intraretinal cystic edema 3. BCVA between 20/40 to 20/400 4. Patient had vitrectomy surgery. 5. Provide a signed informed consent prior to any study procedure
Exclusion criteria
1. Patient unlikely to benefit from intravitreal Ozurdex due to macular ischemia, atrophy, or other condition 2. Patient with history of steroid response with IOP \>35 mm Hg or requirement to be on \> 2 glaucoma medications following previous steroid injection. 3. Previous injection of anti-VEGF or steroid in the study eye within 90 days 4. Vitrectomy, cataract surgery, or YAG capsulotomy within 90 days. 5. Current tractional detachment of the macula or vitreous hemorrhage obscuring details of the macula. 6. Pregnant, lactating females, or females of child-bearing potential that are not using reliable contraception.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity Gain | 13 months | Measured visual acuity gain in number of letters improved as a result of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Central Retinal Thickness Reduction | 1 year | Central Retinal Thickness Reduction as measured by Heidelberg OCT |
| Comparison of Efficacy Between Group 1 and 2 | 3 years | Comparison of efficacy between group 1 and group 2 |
| Visual Acuity Gain at Year 2 and 3 | 3 years | VA gain in ETDRS letters at years 2 and years 3 |
| Time to Reimplantation of Ozurdex Implant | 3 years | Time in months until new implant is needed |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Implant up to Every 3 Mo. Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time \> 3 months following last injection in group 1 if any of the following conditions are met:
1. Increase of \> 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant | 3 |
| Dexamethasone Implant up to Every 6 Mo. Ozurdex (dexamethasone) 0.7 mg implant will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit.
Re-implantation of Ozurdex (dexamethasone) may occur at any time \>6 months following last injection in group 2 if any of the following conditions are met:
1. Increase of \> 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant | 0 |
| Sham Implant Sham Procedure will be performed on Day 0. All patients will be evaluated monthly thereafter.
Intervention: One month following initial implantation/sham, patients will be evaluated for focal or grid laser treatment if the investigator feels the patient will benefit. Also, at 13 months, patients in the sham group will be eligible for Ozurdex (dexamethasone) 0.7 mg implantation if initial inclusion/exclusion criteria are met. These patients would follow re-implantation guidelines of group 2.
Sham implantation may occur at any time \> 6 months following last sham injection in group 3 if any of the following conditions are met:
1. Increase of \> 50 microns from the best previous CRT measurement
2. Recurrence of intraretinal cystic edema
3. Persistent intraretinal cystic edema
Dexamethasone: Ozurdex (dexamethasone) 0.7mg steroid implant | 0 |
| Total | 3 |
Baseline characteristics
| Characteristic | Total | Dexamethasone Implant up to Every 3 Mo. |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 1 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 0 | 69 years STANDARD_DEVIATION 0 |
| Race and Ethnicity Not Collected | 0 Participants | — |
| Region of Enrollment United States | 3 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 3 | 0 / 0 | 0 / 0 |
Outcome results
Primary
Visual Acuity Gain
Measured visual acuity gain in number of letters improved as a result of treatment
Time frame: 13 months
Population: I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.
Secondary
Central Retinal Thickness Reduction
Central Retinal Thickness Reduction as measured by Heidelberg OCT
Time frame: 1 year
Population: I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.
Secondary
Comparison of Efficacy Between Group 1 and 2
Comparison of efficacy between group 1 and group 2
Time frame: 3 years
Population: I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.
Secondary
Time to Reimplantation of Ozurdex Implant
Time in months until new implant is needed
Time frame: 3 years
Population: I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.
Secondary
Visual Acuity Gain at Year 2 and 3
VA gain in ETDRS letters at years 2 and years 3
Time frame: 3 years
Population: I have entered, 0 into the results section due to the fact that this study was terminated early by the study Principal Investigator and no formal medical record extrapolation, database formation, or analysis was conducted.