Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab
Condition: Diabetic Retinopathy; Macular Edema
MeSH terms: Macular Edema; Retinal Diseases; Diabetic Retinopathy; Edema
Intervention: aflibercept
Intervention description: aflibercept 2mg given intravitreally every month until resolution of fluid in retina and then continued every 2 months for a total of 24 months of treatment
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Macular Edema; Diabetic Retinopathy

Summary:

      Treatment of diabetic macular edema with intravitreal aflibercept in subjects previously
      treated with intravitreal anti-Vascular endothelial growth factor (VEGF) agents (ranibizumab
      or bevacizumab)
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women ≥ 18 years of age.

          2. Foveal-involving retinal edema secondary to DME based on investigator review of
             clinical exam and SDOCT with central subfield thickness value of 325 microns by Zeiss
             Cirrus SD-OCT.

          3. E-ETDRS best-corrected visual acuity of: 20/25 to 20/400 in the study eye.

          4. History of previous treatment with anti-VEGF with at least 4 injections over the last
             6 months.

          5. Willing, committed, and able to return for all clinic visits and complete all study
             related procedures.

          6. Able to read, (or, if unable to read due to visual impairment, be read to verbatim by
             the person administering the informed consent or a family member.) understand and
             willing to sign the informed consent form.

             -

        Exclusion Criteria:

          1. Any prior or concomitant therapy with another investigational agent to treat DME in
             the study eye.

          2. Prior panretinal photocoagulation in the study eye within the past 3 months.

          3. Prior intravitreal anti-VEGF therapy in the study eye within 30 days of enrollment.

          4. Prior systemic anti-VEGF therapy, investigational or FDA-approved, is only allowed up
             to 3 months prior to first dose, and will not be allowed during the study.

          5. Previous treatment with intravitreal aflibercept injection

          6. Significant vitreous hemorrhage obscuring view to the macula or the retinal periphery
             as determined by the investigator on clinical exam

          7. Presence of other causes of macular edema, including pathologic myopia (spherical
             equivalent of -8 diopters or more negative, or axial length of 25 mm or more), ocular
             histoplasmosis syndrome, angioid streaks, choroidal rupture, choroidal
             neovascularization, age-related macular degeneration or multifocal choroiditis in the
             study eye.

          8. Presence of macula-threatening traction retinal detachment.

          9. Prior vitrectomy in the study eye.

         10. History of retinal detachment or treatment or surgery for retinal detachment in the
             study eye.

         11. Any history of macular hole of stage 2 and above in the study eye.

         12. Any intraocular or periocular surgery within 3 months of Day 1 on the study eye,
             except lid surgery, which may not have taken place within 1 month of day 1, as long as
             it's unlikely to interfere with the injection.

         13. Uncontrolled glaucoma at baseline evaluation

         14. Active intraocular inflammation in either eye.

         15. Active ocular or periocular infection in either eye.

         16. Any ocular or periocular infection within the last 2 weeks prior to Screening in
             either eye.

         17. Any history of uveitis in either eye.

         18. History of corneal transplant or corneal dystrophy in the study eye.

         19. Significant media opacities, including cataract, in the study eye which might
             interfere with visual acuity, assessment of safety, or fundus photography.

         20. Any concurrent intraocular condition in the study eye (e.g. cataract) that, in the
             opinion of the investigator, could require either medical or surgical intervention
             during the 52 week study period.

         21. Any concurrent ocular condition in the study eye which, in the opinion of the
             investigator, could either increase the risk to the subject beyond what is to be
             expected from standard procedures of intraocular injection, or which otherwise may
             interfere with the injection procedure or with evaluation of efficacy or safety.

         22. Participation as a subject in any clinical study within the 12 weeks prior to Day 1.

         23. Any systemic therapy with an investigational agent in the past 3 months prior to Day
             1.

         24. Any history of allergy to povidone iodine.

         25. Pregnant or breast-feeding women

         26. Women of childbearing potential who are unwilling to practice adequate contraception
             during the study -