Diabetic Macular Edema Treated With Ozurdex (DMEO)
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone Implant; Anti-VEGF injection
Intervention description: Patients will receive a single injection of a dexmethasone implant; Patients will receive PRN injections of an anti-VEGF agent
Intervention MeSH terms: Dexamethasone
Phase: Phase 2
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      To measure various pro-permeability factors in the aqueous humor of patients with
      persistent/recurrent diabetic macular edema
    

Eligibility criteria:

        Inclusion Criteria:

          -  • Signed informed consent and authorization of use and disclosure of protected health
             information

               -  Age more than or equal to 18 years

               -  Diagnosis of diabetic macular edema

               -  Intraretinal or subretinal fluid in the macula determined by Spectralis OCT

               -  Best corrected visual acuity score in the study eye of 20/30 to 20/400 inclusive
                  (Snellen equivalents using the ETDRS protocol at a distance of 4 meters)

               -  In the opinion of the investigator, decreased vision in the study eye is due to
                  foveal thickening from DME and not from other obvious causes of decreased vision

               -  Persistent or recurrent edema despite prolonged treatment with an anti-VEFG agent

        Exclusion Criteria:

          -  • Scatter laser photocoagulation or macular photocoagulation within 3 months of study
             entry in the study eye

               -  Intraocular surgery in the study eye within 3 months of study entry

               -  Use of intraocular or periocular injection of steroids in the study eye (e.g.,
                  triamcinolone) within 4 months of study entry

               -  Previous use of an anti-VEGF drug within 1 month of study entry

               -  Yttrium-Aluminum-Garnet (YAG) laser capsulotomy within 1 month of study entry

               -  Any condition that the investigator believes would pose a significant hazard to
                  the subject if investigational therapy were initiated.

               -  Inability to comply with study or follow up procedures

               -  History of glaucoma. (Patients who have undergone filtration surgery may be
                  included)

               -  Patients with active or suspected ocular or periocular infection, including most
                  viral diseases of the cornea and conjunctiva, including active epithelial herpes
                  simplex keratitis (dendritic keratitis), vaccinia, varicella, mycobacterial
                  infections, and fungal diseases.

               -  Aphakic eyes with rupture of the posterior lens capsule.

               -  Eyes with ACIOL and rupture of the posterior lens capsule.

               -  Patients with hypersensitivity to dexamethasone or to any other components of the
                  product