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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
199
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.
Retina Research Institute, LLC
Phoenix, Arizona, United States
Retinal Consultants of Arizona
Phoenix, Arizona, United States
Sunny View Medical Center
Phoenix, Arizona, United States
Premier Research Group Limited
Phoenix, Arizona, United States
Retina Centers, P.C.
Tucson, Arizona, United States
Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)
Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated early treatment diabetic retinopathy study (ETDRS) charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).
Time frame: Baseline (Day 0) and Week 12
Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12
Refraction and visual acuity were assessed through the BCVA obtained using the retro illuminated ETDRS charts. Distance visual acuity was expressed as an ETDRS score (number of letters correctly read).
Time frame: Baseline (Day 0) and Week 12
Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12
A central reading center was used for the evaluation. A photographer or technician pre certified ("study certified") by the Central Reading Center ought to perform all optical coherence tomography (OCT) imaging. Use of a Spectralis or Cirrus OCT was acceptable.
Time frame: Baseline (Day 0) and Week 12
Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12
Fluorescein Angiography (FA) using certified digital systems was taken by a photographer who had been pre-certified ("study-certified") by the Central Reading Center. They were evaluated by the Central Reading Center.
Time frame: Baseline (Day 0) and Week 12
Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12
Stereo color fundus photographs using certified digital systems were taken by a photographer who had been pre-certified ("study certified") by the Central Reading Center. They were evaluated by the Central Reading Center.
Time frame: Baseline (Day 0) and Week 12
Plasma Concentration of PF-04634817 up to Week 12
Time frame: Week 0, Week 4, Week 8, and Week 12
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Retina Institute of California
Arcadia, California, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, United States
Retinal Diagnostic Center
Campbell, California, United States
Retina Associates of Orange County
Laguna Hills, California, United States
Southern California Desert Retina Consultants
Palm Desert, California, United States
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