Anti-Vascular Endothelial Growth Factor (Anti-VEGF) Alone Versus Ozurdex Given Every 3 Months for Treatment of Persistent Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Ozurdex; Bevacizumab
Intervention description: intravitreal steroid; antiVEGF
Intervention MeSH terms: Dexamethasone; Bevacizumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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