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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Macular Edema, Diabetic

In brief

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 facts

Study ID

NCT01994291

Run by

Pfizer

People needed

199

Starts

2013-11-01

Expected to finish

2015-08-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• 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
• 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
• American Institute of Research (Administrative Only) — Whittier, California, United States
• New England Retina Associates — New London, Connecticut, United States
• Bascom Palmer Eye Institute — Miami, Florida, United States
• Fort Lauderdale Eye Institute — Plantation, Florida, United States
• Center for Retina and Macular Disease — Winter Haven, Florida, United States
• Southeast Retina Center, PC — Augusta, Georgia, United States
• Midwest Eye Institute — Indianapolis, Indiana, United States
• Tufts Medical Center — Boston, Massachusetts, United States
• TLC Eyecare & Laser Center — Jackson, Michigan, United States
• Wm Beaumont Medical Office Building — Royal Oak, Michigan, United States
• Charlotte Eye Ear Nose and Throat Associates PA — Charlotte, North Carolina, United States
• Retina Associates of Cleveland, Inc. — Cleveland, Ohio, United States
• Retina Associates of Cleveland — Youngstown, Ohio, United States
• Dean McGee Eye Institute — Oklahoma City, Oklahoma, United States
• University of Oklahoma -OU Physicians — Oklahoma City, Oklahoma, United States
• Retina Research Institute, LLC — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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