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

Conditions

• Macular Edema, Diabetic

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Ranibizumab — DRUG
  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
• Placebo — DRUG
  Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817. Dose is 4 tablets each day for 12 weeks
• PF-04634817 — DRUG
  Four 50mg tablets PF-04634817 once a day for 12 weeks.
• Masked Sham Therapy — DRUG
  Empty, needle-less syringe is used by the unmasked team once a month.

Study Details

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.

Key Dates

First listed

Nov 25, 2013

Start date

Nov 30, 2013

Status verified

Aug 2016

Primary completion

Aug 31, 2015

Completion

Aug 31, 2015

Study Design

Enrollment

199 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

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

Primary Outcome Measure

Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline (Day 0) and Week 12 ]

Locations (33)

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