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
Condition: Macular Edema, Diabetic
MeSH terms: Macular Edema; Edema
Intervention: Ranibizumab; Placebo; PF-04634817; Masked Sham Therapy
Intervention description: 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; Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.
Dose is 4 tablets each day for 12 weeks; Four 50mg tablets PF-04634817 once a day for 12 weeks.; Empty, needle-less syringe is used by the unmasked team once a month.
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 199.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chemokine Antagonist; Diabetic Macular Edema; Diabetes; Diabetes Mellitus; Macular Edema; Diabetic Retinopathy; Anti-VEGF

Summary:

      The study hypothesis under test is that administration of the CCR2/5 antagonist has the
      potential to be as effective as the current treatment options for subjects with diabetic
      macular edema. The current treatment option for these subjects is an injection directly into
      the eye, while this CCR2/5 antagonist would be an oral drug which has the potential to be
      just as effective. This CCR2/5 antagonist also has a broader anti-inflammatory potential and
      might be able to provide an alternative mechanism to treat Diabetic Macular Edema.
    

Eligibility criteria:

        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.