Macular Edema, Diabetic | 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
Macular Edema, Diabetic research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Macular Edema, Diabetic
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:RanibizumabIntravitreal 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:PlaceboOral 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-04634817Four 50mg tablets PF-04634817 once a day for 12 weeks.
Drug:Masked Sham TherapyEmpty, needle-less syringe is used by the unmasked team once a month.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Arm 1Intravitreal 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.
Arm 2Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
Start Date: November 2013
Completed Date: August 2015
Phase: Phase 2
Primary Outcome: Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)
Secondary Outcome: Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12
Study sponsors, principal investigator, and references
Principal Investigator: Pfizer CT.gov Call Center
Lead Sponsor: Pfizer