Dexamethasone Intravitreal Implant for the Treatment of Persistent Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Dexamethasone intravitreal implant (0.7 mg); Intravitreal anti-VEGF injection
Intervention description: Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).; This injection may be ranibizumab, bevacizumab, or aflibercept.
Intervention MeSH terms: Dexamethasone; Ranibizumab; Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Laser photocoagulation and intravitreal anti-vascular growth factor injections are commonly
      used treatment options for individuals with diabetic macular edema. However, some patients
      continue to experience persistent diabetic macular edema and poor vision despite continued
      laser and/or anti-vegf therapy. Recent clinical trials suggest that due to inflammatory
      mediators dexamethasone intravitreal implant (0.7mg) may be a good alternative therapy for
      individuals unresponsive to laser photocoagulation or intravitreal anti-vascular growth
      factor injections. The purpose of this research study is to compare the effectiveness of
      using a dexamethasone steroid implant versus monthly intravitreal anti-VEGF injections for
      research participants with persistent diabetic macular edema (DME).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Able to provide written informed consent and comply with study assessments for the
             full duration of the study.

          -  Age ≥ 18 years

          -  Diagnosis of diabetes mellitus (type 1 or 2)

               -  Any one of the following will be considered to be sufficient evidence that
                  diabetes is present:

               -  Current regular use of insulin for treatment of diabetes

               -  Current regular use of oral anti-hyperglycemia agent for the treatment of
                  diabetes

          -  Clinical evidence of retinal thickening due to macular edema involving the center of
             the macula associated with diabetic retinopathy.

          -  Previous history of anti-vegf treatment for diabetic macular edema (DME) with
             documented incomplete resolution of central subfield thickening by spectral-domain
             optical coherence tomography (SDOCT). At least 4 intravitreal anti-vegf injections
             within the past six months prior to the baseline study visit are required for
             eligibility.

          -  Central diabetic macular edema present on clinical examination and SDOCT testing with
             central 1 mm subfield thickness greater than 300 microns as measured on SDOCT at the
             baseline visit.

          -  Visual acuity score greater than or equal to 19 letters (20/400) and less than or
             equal to 74 letters (20/32) by the ETDRS visual acuity protocol.

          -  Media clarity, pupillary dilation and patient cooperation sufficient to allow SDOCT
             testing and retinal photography.

        Exclusion Criteria:

          -  Pregnancy (positive pregnancy test) or known to be pregnant; also pre-menopausal women
             not using adequate contraception.

          -  Participation in another ocular investigation or trial simultaneously

          -  Blood pressure > 180/110 mmHg (systolic above 180 OR diastolic above 110 mmHg)

          -  Any condition that, in the opinion of the investigator, would preclude participation
             in the study (e.g. chronic alcoholism, drug abuse)

          -  Evidence of vitreoretinal interface abnormality after ocular exam or OCT that may be
             contributing to the macular edema

          -  An eye that, in the investigator's opinion, has no chance of improving in visual
             acuity following resolution of macular edema (e.g. presence of subretinal fibrosis or
             geographic atrophy)

          -  Presence of another ocular condition that may affect the visual acuity or macular
             edema during the course of the study (e.g. AMD, uveitis, Irvine-Gass)

          -  Evidence of active neovascularization of the iris or retina

          -  Evidence of central atrophy or fibrosis in the study eye

          -  Presence of substantial cataract, one that might decrease the vision by 3 or more
             lines of vision at sometime during the study.

          -  History of vitreous surgery in the study eye

          -  History of cataract surgery within 3 months of enrollment.

          -  History of YAG capsulotomy within 2 months of enrollment.

          -  Visual acuity <20/400 on ETDRS visual acuity charts in the fellow eye

          -  Uncontrolled glaucoma (pressure > 30 mmHg) despite treatment with glaucoma
             medications.

          -  History of cerebral vascular accident or myocardial infarction within 3 months prior
             to Day 0.

          -  Use of systemic steroids (eg, oral, intravenous, intramuscular, epidural, rectal, or
             extensive dermal) within one month prior to the baseline study visit