Diabetic Macular Edema, Epiretinal Membrane
Conditions
Keywords
Diabetes, Macular Edema, Epiretinal Membrane, Vitrectomy
Brief summary
This study will examine the use of the dexamethasone implant (Ozurdex) in patients with macular edema associated with an epiretinal or preretinal membrane requiring surgical intervention. After the surgery is performed (pars plana vitrectomy), an Ozurdex implant will be placed in the eye. Patients will be followed for 1 year.
Detailed description
The purpose of this study to examine the use of Ozurdex in patients who are undergoing pars plana vitrectomy for macular edema due to preretinal membranes. Specifically, we will examine its effect on macular edema (measured by OCT), and visual recovery (measured by visual acuity). We will examine its use in patients who underwent pars plana vitrectomy for macular edema with associated taut membrane. This will be a prospective pilot study with patients to receive an Ozurdex implant at the time of vitrectomy.
Interventions
DRUGOzurdex
Ozurdex .7 mg injected into the treated eye
Sponsors
Allergan
The Cleveland Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Patients who are undergoing pars plana vitrectomy for: * Epiretinal membrane/vitreomacular traction or * Diabetic macular edema 2. Patients with macular edema as measured by OCT (at least 250 um central subfoveal thickness) 3. Informed consent requirements: All study subjects must agree to participate in the study and provide written informed consent, which will be written in English. 4. Age between 18-85 years old
Exclusion criteria
1. Age \< 18 years or \> 85 years 2. History of macular edema due to diseases other than those in the inclusion criteria in the study eye * History of active inflammatory eye disease (uveitis) (within 3 months) * History of ocular malignancy and/or ocular/orbital irradiation * History of recent retinal vein occlusion (within 6 months) * History of neovascular age-related macular degeneration or choroidal neovascular membrane \[ * History of juxtafoveal telangiectasia * History of Coat's disease * History central serous choroidoretinopathy * History of previous infectious retinitis (toxoplasmosis, acute retinal necrosis, tuberculosis, etc) 3. Patients with a history of intraocular infection in the study eye (i.e. viral retinitis, endophthalmitis) 4. Patients who are cognitively impaired or those who are unable to provide informed written consent 5. Patients with a history of glaucoma in the study eye (defined as increased cup to disc ratio with associated nerve damage. Patients with ocular hypertension controlled by topical glaucoma drops (maximum 3) will not be excluded). 6. Patient with recent intravitreal injections of steroids or anti-VEGF medications in the study eye (within past 4 weeks). 7. Patients with recent periocular steroid injection (within past 4 weeks) in the study eye 8. Patients on topical NSAIDS drops (patient will be eligible if they discontinue use of topical NSAIDs at time of study enrollment) in the study eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Retinal Thickness | 3 months | At 3 months, central retinal thickness as measured by optical coherence tomography will be measured |
| Visual Acuity | 3 months | ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ozurdex Subjects will receive Ozurdex injections and will be monitored for macular edema.
Ozurdex: Ozurdex .7 mg injected into the treated eye | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 4 |
| Overall Study | screen failures | 3 |
Baseline characteristics
| Characteristic | Ozurdex | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 30 Participants | — |
| Age, Continuous | 61.63 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 30 Participants | — |
| Sex: Female, Male Female | 12 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 27 / 30 |
| serious Total, serious adverse events | 7 / 30 |
Outcome results
Primary
Central Retinal Thickness
At 3 months, central retinal thickness as measured by optical coherence tomography will be measured
Time frame: 3 months
Population: Optical Coherence Tomography was collected at 3 months. 22 of the patients were seen at month 3.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ozurdex | Central Retinal Thickness | 350 micrometers |
Primary
Visual Acuity
ETDRS visual acuity will be measured at 3 months. Visual function of the study eye was assessed using the ETDRS protocol, which is a widely accepted international standard. A higher letter score represents better functioning.
Time frame: 3 months
Population: 23 of the participants were able to come in for their 3 month appointment per protocol
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Ozurdex | Visual Acuity | 56 ETDRS |