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



Status:Terminated
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2013
End Date:August 2015

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A Phase 2, Randomized, Double-masked, Placebo-controlled, Parallel Group, Multi-center Study To Compare The Efficacy And Safety Of A Chemokine Ccr2/5 Receptor Antagonist (Pf-04634817) With That Of Ranibizumab In Adult Subjects With Diabetic Macular Edema

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.

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.
We found this trial at
28
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Royal Oak, Michigan 48073
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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900 Northwest 17th Street
Miami, Florida 33136
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Arcadia, California 91007
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Augusta, Georgia 30909
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Austin, Texas 78705
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Beverly Hills, California 90211
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Campbell, California 95008
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Charlotte, North Carolina 28210
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Cleveland, Ohio 44130
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Houston, Texas 77030
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Indianapolis, Indiana 46290
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Jackson, Michigan 49202
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Laguna Hills, California 92653
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New London, Connecticut 06320
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Oklahoma City, Oklahoma 73104
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Palm Desert, California 92211
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Phoenix, Arizona 85014
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Pittsburgh, Pennsylvania 15213
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Plantation, Florida 33324
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Rapid City, South Dakota 57701
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Salt Lake City, Utah 84107
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San Antonio, Texas 78240
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Sofia,
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Tucson, Arizona 85704
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West Mifflin, Pennsylvania 15122
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Winter Haven, Florida 33880
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Youngstown, Ohio 44505
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