Ozurdex for Diabetic Macular Edema Treated With Pars Plana vitrEctomy and Membrane RemovAl (OPERA Study)
Condition: Diabetic Macular Edema; Epiretinal Membrane
MeSH terms: Macular Edema; Epiretinal Membrane; Edema
Intervention: Ozurdex
Intervention description: Ozurdex .7 mg injected into the treated eye
Intervention MeSH terms: Dexamethasone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Diabetes; Macular Edema; Epiretinal Membrane; Vitrectomy

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.
    

Eligibility criteria:

        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