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
- Interventions
- Registration Number
- NCT01994291
- Lead Sponsor
- Pfizer
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 199
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1 Ranibizumab 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 Masked Sham Therapy Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly). Arm 1 Placebo 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 PF-04634817 Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
- Primary Outcome Measures
Name Time Method Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA) Baseline (Day 0) and Week 12 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).
- Secondary Outcome Measures
Name Time Method Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12 Baseline (Day 0) and 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).
Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12 Baseline (Day 0) and 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.
Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12 Baseline (Day 0) and 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.
Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12 Baseline (Day 0) and 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.
Plasma Concentration of PF-04634817 up to Week 12 Week 0, Week 4, Week 8, and Week 12
Trial Locations
- Locations (63)
Retinal Diagnostic Center
🇺🇸Campbell, 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
Center for Retina and Macular Disease
🇺🇸Winter Haven, Florida, United States
Retina Associates of Orange County
🇺🇸Laguna Hills, California, United States
Fort Lauderdale Eye Institute
🇺🇸Plantation, Florida, United States
Southeast Retina Center, PC
🇺🇸Augusta, Georgia, United States
Retina Vitreous Consultants
🇺🇸Pittsburgh, Pennsylvania, United States
Bascom Palmer Eye Institute
🇺🇸Miami, Florida, United States
Midwest Eye Institute
🇺🇸Indianapolis, Indiana, United States
Charlotte Eye Ear Nose and Throat Associates PA
🇺🇸Charlotte, North Carolina, United States
Dean McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Fakultni nemocnice Ostrava, lekarna
🇨🇿Ostrava - Poruba, Czech Republic
Bajcsy-Zsilinszky Korhaz, Szemeszet
🇭🇺Budapest, Hungary
Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika
🇨🇿Praha 10, Czech Republic
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika
🇭🇺Debrecen, Hungary
Hadassah Medical Organization, Hadassah Medical Center, Ein Karem
🇮🇱Jerusalem, Israel
Ganglion Orvosi Kozpont
🇭🇺Pecs, Hungary
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
MC Comac Medical
🇧🇬Sofia, Bulgaria
Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna
🇨🇿Praha 10, Czech Republic
Meir Medical Center
🇮🇱Kfar Saba, Israel
Universitätsklinikum Regensburg
🇩🇪Regensburg, Bavaria, Germany
Fakultní nemocnice Hradec Králové, Ocni klinika
🇨🇿Hradec Kralove, Czech Republic
Fakultni nemocnice Ostrava, Ocni klinika
🇨🇿Ostrava - Poruba, Czech Republic
Spitalul Clinic Republican
🇲🇩Chisinau, Moldova, Republic of
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki
🇵🇱Wroclaw, Poland
Semmelweis Egyetem, Szemészeti Klinika
🇭🇺Budapest, Hungary
Fakultní nemocnice Hradec Králové, Nemocnicni lekarna
🇨🇿Hradec Kralove, Czech Republic
Csolnoky Ferenc Korhaz, Szemeszeti Osztaly
🇭🇺Veszprem, Hungary
Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu"
🇷🇴Bucuresti, Romania
Premier Research Group Limited
🇺🇸Phoenix, Arizona, United States
Budapest Retina Associates Kft.
🇭🇺Budapest, Hungary
Rabin Medical Center, Beilinson Hospital
🇮🇱Petah Tikva, Israel
Sunny View Medical Center
🇺🇸Phoenix, Arizona, United States
Retina Centers, P.C.
🇺🇸Tucson, Arizona, United States
Retina Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Retina Institute of California
🇺🇸Arcadia, California, United States
Retina Associates of Cleveland
🇺🇸Youngstown, Ohio, United States
Retina Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Retina Associates of Cleveland, Inc.
🇺🇸Cleveland, Ohio, United States
Brain B.Berger,MD,PA
🇺🇸Austin, Texas, United States
Wm Beaumont Medical Office Building
🇺🇸Royal Oak, Michigan, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Medical Center Ophthalmology Associates
🇺🇸San Antonio, Texas, United States
Rocky Mountain Retina Consultants
🇺🇸Salt Lake City, Utah, United States
Associates in Ophthalmology Ltd
🇺🇸West Mifflin, Pennsylvania, United States
Retina Research Center
🇺🇸Austin, Texas, United States
Retina Consultants of Houston, PA
🇺🇸Houston, Texas, United States
Universitatsmedizin Mainz
🇩🇪Mainz, Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
🇩🇪Berlin, Germany
Knappschaftsklinikum GmbH
🇩🇪Sulzbach, Saar, Germany
Universitatsklinikum Tubingen
🇩🇪Tubingen, Germany
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Kaplan Medical Center
🇮🇱Rehovot, Israel
Med Life SA, Sectia Oftalmologie
🇷🇴Bucuresti, Romania
Universitaetsmedizin Goettingen
🇩🇪Goettingen, Germany
Augenärzte am St. Franziskus-Hospital
🇩🇪Muenster, Germany
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
TLC Eyecare & Laser Center
🇺🇸Jackson, Michigan, United States
University of Oklahoma -OU Physicians
🇺🇸Oklahoma City, Oklahoma, United States