IAI for Persistent DME After Treatment With Bevacizumab And Ranibizumab
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema
Intervention: Alflibercept
Intervention description: Intravitreal Injection
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: 95 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a phase 4 prospective, nonrandomized, open label, interventional clinical trial.
      Study eyes will receive 5 required initial monthly Intravitreal Aflibercept (IAI) doses of 2
      mg followed by 2q8 IAI for a total of 52 weeks; only one study eye from each patient will be
      enrolled.
    

Eligibility criteria:

        Inclusion Criteria:

        A patient must meet the following criteria to be eligible for inclusion in the study:

        1. Adults with Diabetes Mellitus 2. Documented history of ROTATE study completion (within 3
        months +/- 1 week of exit visit) 3. BCVA ETDRS visual acuity letter score 20/25-20/400 4.
        Thickening due to DME involving the center of the macula evident on clinical exam 5. DME on
        OCT at baseline (>305 microns if male or >290 microns if female) as assessed on Heidelberg
        Spectralis SD OCT 6. At least 30 days but less than 45 days since prior 0.3 mg ranibizumab
        injection 7. Willing and able to comply with clinic visits and study-related procedures 8.
        Provide signed HIPAA statement and informed consent prior to any study procedures

        -

        Exclusion Criteria:

        A patient who meets any of the following criteria will be excluded from the study:

          1. Macular edema considered to be due to a cause other than DME (ERM, Vein Occlusion,
             Postop CME, uveitis)

          2. History of PRP within 3 months prior to enrollment or anticipated need for PRP

          3. History of idiopathic or autoimmune uveitis in the study eye

          4. Cataract surgery in the study eye within 90 days of baseline

          5. Any intraocular surgery within 90 days of baseline

          6. Vitreomacular traction or epiretinal membrane in the study eye that is thought to
             affect vision

          7. Clinically significant pre-retinal fibrosis involving the macula in the study eye per
             investigator judgment

          8. Intraocular inflammation of trace or above in the study eye

          9. Evidence of active infection in either eye

         10. Uncontrolled glaucoma in the study eye defined as a pressure of > 25 on maximal
             medical therapy.

         11. Concurrent disease in the study eye, other than DME, that could compromise VA, require
             medical or surgical intervention during the study or could confound interpretation of
             the results

         12. Ocular media of insufficient quality to obtain fundus and OCT images

         13. Current treatment for a serious systemic infection

         14. Administration of systemic anti-angiogenic agents within 180 days of screen

         15. History of yag capsulotomy within 1 month prior to enrollment

         16. Receipt of any treatment for DME, other than ranibizumab 0.3 mg, in the study eye at
             any time in the past 3 months following ROTATE study exit, (such as focal/grid macular
             photocoagulation, intravitreal or peribulbar corticosteroids or other anti-VEGF agents
             such as Macugen, 2 mg IAI,, 0.5 mg ranibizumab, or intravitreal bevacizumab)

         17. Any women who are pregnant, breast-feeding, or attempting to become pregnant

         18. Sexually active men* or women of childbearing potential** who are unwilling to
             practice adequate contraception during the study (adequate contraceptive measures
             include stable use of oral contraceptives or other prescription pharmaceutical
             contraceptives for 2 or more menstrual cycles prior to screening; intrauterine device
             [IUD]; bilateral tubal ligation; vasectomy; condom plus contraceptive sponge, foam, or
             jelly, or diaphragm plus contraceptive sponge, foam, or jelly)

               -  Contraception is not required for men with documented vasectomy. **Postmenopausal
                  women must be amenorrheic for at least 12 months in order not to be considered of
                  child bearing potential. Pregnancy testing and contraception are not required for
                  women with documented hysterectomy or tubal ligation.