Wet Macular Degeneration Study to Compare Ranibizumab or Bevacizumab to Aflibercept
Condition: Exudative Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: Aflibercept
Intervention description: Patients received 2 mg (0.05 mL) of intravitreal aflibercept injection administered monthly for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.
Intervention MeSH terms: Aflibercept
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Exudative Macular Degeneration; Aflibercept

Summary:

      This study will examine the use of Aflibercept in patients with exudative macular
      degeneration requiring intravitreal injections. Patients will be followed for 24 months. The
      follow up phase will be completed at month 36.
    

Eligibility criteria:

        Inclusion Criteria

        A subject must meet the following criteria to be eligible for inclusion in the study:

          1. Signed Informed Consent.

          2. Men and women ≥ 50 years of age.

          3. Active primary subfoveal choroidal neovascularization (CNV) lesions secondary to AMD,
             including juxtafoveal lesions that affect the fovea as evidenced by historical optical
             coherence tomographies (OCTs) and angiograms in the study eye.

          4. CNV must be at least 50% of total lesion size by either previous or current angiogram.

          5. ETDRS best-corrected visual acuity of: 20/25 to 20/320 (letter score of 73 to 25) in
             the study eye.

          6. Willing, committed, and able to return for all clinic visits and complete all study
             related procedures.

          7. At least one injection of Ranibizumab or Bevacizumab within 3 months of enrollment for
             active exudative AMD.

          8. Active need for anti- vascular endothelial growth factor (anti-VEGF) therapy at study
             entry based on the following criteria:

               1. Presence of fluid by either optical coherence tomography (OCT) or clinical
                  examination (further defined as intraretinal, cystoid, subretinal, worsening
                  pigment epithelial detachment)

               2. Presence of new hemorrhage on clinical examination

        Exclusion Criteria

        A subject who meets any of the following criteria will be excluded from the study:

          1. Any prior or concomitant therapy with another investigational agent to treat
             neovascular AMD in the study eye, except dietary supplements or vitamins.

          2. Prior systemic anti-VEGF therapy, investigational or FDA/Health Canada approved, is
             only allowed up to 3 months prior to first dose, and will not be allowed during the
             study.

          3. Presence of retinal pigment epithelial tears or rips involving the macula in the study

          4. History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye.

          5. Presence of other causes of CNV, 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, or multifocal choroiditis in the study
             eye.

          6. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any
             other vascular disease affecting the retina, other than AMD, in either eye.

          7. Prior vitrectomy in the study eye.

          8. History of retinal detachment or treatment or surgery for retinal detachment in the
             study eye.

          9. Any history of macular hole of stage 2 and above in the study eye.

         10. 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.

         11. Prior trabeculectomy or other filtration surgery in the study eye.

         12. Uncontrolled glaucoma at baseline evaluation (defined as intraocular pressure ≥25 mmHg
             despite treatment with anti-glaucoma medication) in the study eye.

         13. Active intraocular inflammation in either eye.

         14. Active ocular or periocular infection in either eye.

         15. Any ocular or periocular infection within the last 2 weeks prior to Screening in
             either eye.

         16. Any history of uveitis in either eye.

         17. Active scleritis or episcleritis in either eye.

         18. Presence or history of scleromalacia in either eye.

         19. Aphakia or pseudophakia with absence of posterior capsule (unless it occurred as a
             result of a yttrium aluminum garnet (YAG) posterior capsulotomy) in the study eye.

         20. Previous therapeutic radiation in the region of the study eye.

         21. History of corneal transplant or corneal dystrophy in the study eye.

         22. Significant media opacities, including cataract, in the study eye which might
             interfere with visual acuity, assessment of safety, or fundus photography.

         23. 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.

         24. 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.

         25. Participation as a subject in any clinical study within the 12 weeks prior to Day 1.

         26. Any systemic with an investigational agent in the past 3 months prior to Day 1.

         27. The use of long acting intraocular steroids or photodynamic therapy in the 6 months
             prior to day 1.

         28. Any history of allergy to povidone iodine.

         29. Pregnant or breast-feeding women

         30. 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)

               -  *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.