Conditions: Macular Edema, Diabetic
Keywords: Chemokine Antagonist Diabetic Macular Edema Diabetes Diabetes Mellitus Macular Edema Diabetic Retinopathy Anti-VEGF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 199
Healthy volunteers: no

Brief 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.

Detailed description:
Study recruitment was stopped on April 9, 2015. This decision was taken for business reasons due to changes in the prioritization of the drug development portfolio. This decision was not as a result of any evolving safety, efficacy issue or changes in the risk:benefit assessment of this product or regulatory interactions.

Arms:
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. arm 2: Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).

Interventions: intervention 1: Ranibizumab intervention 2: Placebo intervention 3: PF-04634817 intervention 4: Masked Sham Therapy
Intervention descriptions: intervention 1: 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 intervention 2: Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.

Dose is 4 tablets each day for 12 weeks intervention 3: Four 50mg tablets PF-04634817 once a day for 12 weeks. intervention 4: Empty, needle-less syringe is used by the unmasked team once a month.

Protocol document: