A Phase 2, Multi-Center Study To Compare The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist With Ranibizumab In Adults With Diabetic Macular Edema

• Drug: Ranibizumab

  Intravitreal Injection supplied as:

  • 10 mg/mL in a 0.2 mL vial with instructions on preparation and administration of the 0.5 mg (0.05 mL) dose.
  • 6 mg/mL in a single use vial with instructions on preparation and administration of the 0.3 mg (0.05 mL) dose.
  • Adminstered once a month for 12 weeks
• Drug: Placebo

  Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.

  Dose is 4 tablets each day for 12 weeks

• Drug: PF-04634817
  Four 50mg tablets PF-04634817 once a day for 12 weeks.
• Drug: Masked Sham Therapy
  Empty, needle-less syringe is used by the unmasked team once a month.

• Active Comparator: Arm 1
  Intravitreal administration of ranibizumab (either 0.3 or 0.5 mg, given monthly, as detailed in the prescribing information and label content approved for the country governing the study site) plus an oral placebo.
  Interventions:

  • Drug: Ranibizumab
  • Drug: Placebo
• Experimental: Arm 2
  Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
  Interventions:

  • Drug: PF-04634817
  • Drug: Masked Sham Therapy

Inclusion Criteria:

• Patients with Diabetes Mellitus (Type 1 or Type 2) Showing Diabetic Macular Edema in the Eye
• Reduced visual acuity resulting from retinal thickening
• Female subjects of non-childbearing potential ?18 years and male subjects greater than or equal to 18 years. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.

• Female subjects who are not of childbearing potential must meet at least one of the following criteria:

  • Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  • Have medically confirmed ovarian failure; or
  • Achieved post-menopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level within the laboratory's reference range for postmenopausal females.

Exclusion Criteria:

• Severe Impaired Renal Function
• Any intraocular condition or previous surgery in either eye that would likely require medical or surgical intervention during the study duration or if allowed to progress untreated for the 16 weeks of study duration, would likely contribute to a reduction in visual acuity.