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
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
2 other identifiers
interventional
199
9 countries
63
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2013
63 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 8, 2013
CompletedFirst Posted
Study publicly available on registry
November 25, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedResults Posted
Study results publicly available
October 17, 2016
CompletedOctober 17, 2016
August 1, 2016
1.7 years
November 8, 2013
July 5, 2016
August 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Baseline (Day 0) and Week 12
Secondary Outcomes (5)
Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12
Baseline (Day 0) and Week 12
Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12
Baseline (Day 0) and Week 12
Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12
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
Baseline (Day 0) and Week 12
Plasma Concentration of PF-04634817 up to Week 12
Week 0, Week 4, Week 8, and Week 12
Other Outcomes (7)
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Week 0 to Week 16
Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs
Week -5 to Week 16
Number of Participants With Laboratory Abnormalities
Week -5 to Week 16
- +4 more other outcomes
Study Arms (2)
Arm 1
ACTIVE COMPARATORIntravitreal 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
EXPERIMENTALOral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
Interventions
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
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (63)
Retina Research Institute, LLC
Phoenix, Arizona, 85014, United States
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
Sunny View Medical Center
Phoenix, Arizona, 85018, United States
Premier Research Group Limited
Phoenix, Arizona, 85027, United States
Retina Centers, P.C.
Tucson, Arizona, 85704, United States
Retina Institute of California
Arcadia, California, 91007, United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
Retina Associates of Orange County
Laguna Hills, California, 92653, United States
Southern California Desert Retina Consultants
Palm Desert, California, 92211, United States
American Institute of Research (Administrative Only)
Whittier, California, 90603, United States
New England Retina Associates
New London, Connecticut, 06320, United States
Bascom Palmer Eye Institute
Miami, Florida, 33136, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center, PC
Augusta, Georgia, 30909, United States
Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
TLC Eyecare & Laser Center
Jackson, Michigan, 49202, United States
Wm Beaumont Medical Office Building
Royal Oak, Michigan, 48073, United States
Charlotte Eye Ear Nose and Throat Associates PA
Charlotte, North Carolina, 28210, United States
Retina Associates of Cleveland, Inc.
Cleveland, Ohio, 44122, United States
Retina Associates of Cleveland
Youngstown, Ohio, 44505, United States
Dean McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
University of Oklahoma -OU Physicians
Oklahoma City, Oklahoma, 73104, United States
Retina Vitreous Consultants
Pittsburgh, Pennsylvania, 15213, United States
Associates in Ophthalmology Ltd
West Mifflin, Pennsylvania, 15122, United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701, United States
Brain B.Berger,MD,PA
Austin, Texas, 78705, United States
Retina Research Center
Austin, Texas, 78705, United States
Retina Consultants of Houston, PA
Houston, Texas, 77030, United States
Medical Center Ophthalmology Associates
San Antonio, Texas, 78240, United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107, United States
MC Comac Medical
Sofia, 1612, Bulgaria
Fakultní nemocnice Hradec Králové, Ocni klinika
Hradec Králové, 500 05, Czechia
Fakultní nemocnice Hradec Králové, Nemocnicni lekarna
Hradec Králové, 50005, Czechia
Fakultni nemocnice Ostrava, lekarna
Ostrava - Poruba, 70852, Czechia
Fakultni nemocnice Ostrava, Ocni klinika
Ostrava - Poruba, 70852, Czechia
Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika
Prague, 10034, Czechia
Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna
Prague, 10034, Czechia
Universitätsklinikum Regensburg
Regensburg, Bavaria, 93053, Germany
Universitaetsklinikum Muenster
Münster, Germany, 48159, Germany
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
Berlin, 12200, Germany
Universitaetsmedizin Goettingen
Göttingen, 37075, Germany
Universitatsmedizin Mainz
Mainz, 55131, Germany
Augenärzte am St. Franziskus-Hospital
Münster, 48145, Germany
Knappschaftsklinikum GmbH
Sulzbach, 66280, Germany
Universitatsklinikum Tubingen
Tübingen, 72076, Germany
Semmelweis Egyetem, Szemészeti Klinika
Budapest, 1083, Hungary
Bajcsy-Zsilinszky Korhaz, Szemeszet
Budapest, 1106, Hungary
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika
Debrecen, 4032, Hungary
Ganglion Orvosi Kozpont
Pécs, 7621, Hungary
Csolnoky Ferenc Korhaz, Szemeszeti Osztaly
Veszprém, 8200, Hungary
Hadassah Medical Organization, Hadassah Medical Center, Ein Karem
Jerusalem, 91120, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, 49100, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Spitalul Clinic Republican
Chisinau, MD-2025, Moldova
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki
Wroclaw, 50-367, Poland
Med Life SA, Sectia Oftalmologie
Bucharest, 010719, Romania
Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu"
Bucharest, 020475, Romania
Related Publications (1)
Gale JD, Berger B, Gilbert S, Popa S, Sultan MB, Schachar RA, Girgenti D, Perros-Huguet C. A CCR2/5 Inhibitor, PF-04634817, Is Inferior to Monthly Ranibizumab in the Treatment of Diabetic Macular Edema. Invest Ophthalmol Vis Sci. 2018 May 1;59(6):2659-2669. doi: 10.1167/iovs.17-22731.
PMID: 29847672DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer, Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2013
First Posted
November 25, 2013
Study Start
November 1, 2013
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
October 17, 2016
Results First Posted
October 17, 2016
Record last verified: 2016-08