Back to resultsA 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
Primary Purpose
Macular Edema, Diabetic
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Ranibizumab
Placebo
PF-04634817
Masked Sham Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Macular Edema, Diabetic focused on measuring Chemokine Antagonist, Diabetic Macular Edema, Diabetes, Diabetes Mellitus, Macular Edema, Diabetic Retinopathy, Anti-VEGF
Eligibility Criteria
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.
Sites / Locations
- Retina Research Institute, LLC
- Retinal Consultants of Arizona
- Sunny View Medical Center
- Premier Research Group Limited
- Retina Centers, P.C.
- Retina Institute of California
- Retina Vitreous Associates Medical Group
- Retinal Diagnostic Center
- Retina Associates of Orange County
- Southern California Desert Retina Consultants
- American Institute of Research (Administrative Only)
- New England Retina Associates
- Bascom Palmer Eye Institute
- Fort Lauderdale Eye Institute
- Center for Retina and Macular Disease
- Southeast Retina Center, PC
- Midwest Eye Institute
- Tufts Medical Center
- TLC Eyecare & Laser Center
- Wm Beaumont Medical Office Building
- Charlotte Eye Ear Nose and Throat Associates PA
- Retina Associates of Cleveland, Inc.
- Retina Associates of Cleveland
- Dean McGee Eye Institute
- University of Oklahoma -OU Physicians
- Retina Vitreous Consultants
- Associates in Ophthalmology Ltd
- Black Hills Regional Eye Institute
- Brain B.Berger,MD,PA
- Retina Research Center
- Retina Consultants of Houston, PA
- Medical Center Ophthalmology Associates
- Rocky Mountain Retina Consultants
- MC Comac Medical
- Fakultní nemocnice Hradec Králové, Ocni klinika
- Fakultní nemocnice Hradec Králové, Nemocnicni lekarna
- Fakultni nemocnice Ostrava, lekarna
- Fakultni nemocnice Ostrava, Ocni klinika
- Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika
- Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna
- Universitätsklinikum Regensburg
- Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
- Universitaetsmedizin Goettingen
- Universitatsmedizin Mainz
- Augenärzte am St. Franziskus-Hospital
- Universitaetsklinikum Muenster
- Knappschaftsklinikum GmbH
- Universitatsklinikum Tubingen
- Semmelweis Egyetem, Szemészeti Klinika
- Bajcsy-Zsilinszky Korhaz, Szemeszet
- Budapest Retina Associates Kft.
- Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika
- Ganglion Orvosi Kozpont
- Csolnoky Ferenc Korhaz, Szemeszeti Osztaly
- Hadassah Medical Organization, Hadassah Medical Center, Ein Karem
- Meir Medical Center
- Rabin Medical Center, Beilinson Hospital
- Kaplan Medical Center
- Tel Aviv Sourasky Medical Center
- Spitalul Clinic Republican
- Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki
- Med Life SA, Sectia Oftalmologie
- Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu"
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Arm 1
Arm 2
Arm Description
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.
Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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.
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.
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.
Plasma Concentration of PF-04634817 up to Week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01994291
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Study Start Date
November 2013 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Diabetic
Keywords
Chemokine Antagonist, Diabetic Macular Edema, Diabetes, Diabetes Mellitus, Macular Edema, Diabetic Retinopathy, Anti-VEGF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Active Comparator
Arm Description
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 Title
Arm 2
Arm Type
Experimental
Arm Description
Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.
Dose is 4 tablets each day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
PF-04634817
Intervention Description
Four 50mg tablets PF-04634817 once a day for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Masked Sham Therapy
Intervention Description
Empty, needle-less syringe is used by the unmasked team once a month.
Primary Outcome Measure Information:
Title
Mean Letter Change From Baseline at Week 12 in Best Corrected Visual Acuity (BCVA)
Description
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
Secondary Outcome Measure Information:
Title
Proportion of Subjects Gaining 15 ETDRS Letters in BCVA From Baseline at Week 12
Description
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
Title
Mean Change From Baseline in Central Subfield Retinal Thickness in the Study Eye at Week 12
Description
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
Title
Mean Change From Baseline in The Area of Fluorescein Leakage in the Study Eye at Week 12
Description
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
Title
Mean Change From Baseline in Steps of Diabetic Retinopathy Step (ETDRS Severity Scale) in the Study Eye at Week 12
Description
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
Title
Plasma Concentration of PF-04634817 up to Week 12
Time Frame
Week 0, Week 4, Week 8, and Week 12
Other Pre-specified Outcome Measures:
Title
Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
Description
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. A SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time Frame
Week 0 to Week 16
Title
Number of Participants With Potentially Clinically Important Post-Baseline Vital Signs
Description
Number of participants who met the categorical summary of post-baseline criteria at any time point, defined as: supine pulse rate <40 beats per minute (bpm) or >120 bpm; supine systolic blood pressure (SBP) ≥30 millimeters of mercury (mmHg) change from baseline in same posture; supine diastolic BP (DBP) ≥20 mmHg change from baseline in same posture; supine SBP <90 mmHg; supine DBP <50 mmHg.
Time Frame
Week -5 to Week 16
Title
Number of Participants With Laboratory Abnormalities
Description
The following laboratory parameters were analyzed for abnormalities at any time point: hematology (hemoglobin, hematocrit, red blood cell count (RBC), white blood cell count (WBC) with differential, and platelet count); blood chemistry (sodium, potassium, chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, albumin, calcium, total, direct and indirect bilirubin, gamma glutamyltransferase (GGT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactic dehydrogenase (LDH), alkaline phosphatase, creatine phosphokinase (CPK), uric acid, amylase and lipase); follicle-stimulating hormone (FSH) (Weeks -5 to 0 only, for postmenopausal women who have been amenorrheic for at least 12 consecutive months prior to screening visit).
Time Frame
Week -5 to Week 16
Title
Number of Participants With Potentially Clinically Significant Electrocardiogram (ECG) Findings
Description
ECG parameters included PR interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for ECG changes meeting potential clinical concern included: PR interval greater than or equal to (>=)300 milliseconds (msec) or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QRS interval >=200 msec or >=25% increase when baseline is greater than (>)200 msec and >=50% increase when baseline is less than or equal to (≤)200 msec; QT interval >=500 msec; and QTcF >=450 msec or >=30 msec increase. The number of participants with potentially clinically significant ECG findings at any visit were reported.
Time Frame
Week -5 to Week 16
Title
Number of Participants With Changes in the Anterior Segment of the Study Eye at Week 12
Description
The anterior biomicroscopy exam was done undilated in order to assess whether there was any anterior segment inflammation caused either by ranibizumab or PF-04634817.
Time Frame
Week -5 to Week 16
Title
Maximum Increase of Intraocular Pressure (IOP) From Baseline in Study Eye
Description
IOP was measured using Goldmann applanation tonometry. To maintain consistency, it was recommended that the same examiner ought to measure IOP with the same tonometer at each visit for a given subject. Intraocular pressure ought to be measured in the study eye approximately 30 minutes after intravitreal injection or masked sham therapy (performed by unmasked study team member).
Time Frame
Week -5 to Week 16
Title
Number of Participants With Change in Ophthalmoscopy Examination Results in Study Eye After Administration of Ranibizumab or Masked Sham Therapy at Week 8
Description
Ophthalmoscopy ought to be performed after pupillary dilation to examine the vitreous body, optic nerve head, macular and peripheral retina. All findings, including the presence or absence of vitreous inflammation, ought to be documented. All post-dose ophthalmoscopy assessments ought to be made immediately following the administration of ranibizumab or masked sham therapy.
Time Frame
Week -5 to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Retina Research Institute, LLC
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Sunny View Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Premier Research Group Limited
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Retina Centers, P.C.
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Retina Institute of California
City
Arcadia
State/Province
California
ZIP/Postal Code
91007
Country
United States
Facility Name
Retina Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Retinal Diagnostic Center
City
Campbell
State/Province
California
ZIP/Postal Code
95008
Country
United States
Facility Name
Retina Associates of Orange County
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Southern California Desert Retina Consultants
City
Palm Desert
State/Province
California
ZIP/Postal Code
92211
Country
United States
Facility Name
American Institute of Research (Administrative Only)
City
Whittier
State/Province
California
ZIP/Postal Code
90603
Country
United States
Facility Name
New England Retina Associates
City
New London
State/Province
Connecticut
ZIP/Postal Code
06320
Country
United States
Facility Name
Bascom Palmer Eye Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Fort Lauderdale Eye Institute
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Winter Haven
State/Province
Florida
ZIP/Postal Code
33880
Country
United States
Facility Name
Southeast Retina Center, PC
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
TLC Eyecare & Laser Center
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49202
Country
United States
Facility Name
Wm Beaumont Medical Office Building
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates PA
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Retina Associates of Cleveland, Inc.
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Retina Associates of Cleveland
City
Youngstown
State/Province
Ohio
ZIP/Postal Code
44505
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Oklahoma -OU Physicians
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Retina Vitreous Consultants
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Associates in Ophthalmology Ltd
City
West Mifflin
State/Province
Pennsylvania
ZIP/Postal Code
15122
Country
United States
Facility Name
Black Hills Regional Eye Institute
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Brain B.Berger,MD,PA
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Research Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina Consultants of Houston, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical Center Ophthalmology Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Rocky Mountain Retina Consultants
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
MC Comac Medical
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Fakultní nemocnice Hradec Králové, Ocni klinika
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
Facility Name
Fakultní nemocnice Hradec Králové, Nemocnicni lekarna
City
Hradec Kralove
ZIP/Postal Code
50005
Country
Czech Republic
Facility Name
Fakultni nemocnice Ostrava, lekarna
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Fakultni nemocnice Ostrava, Ocni klinika
City
Ostrava - Poruba
ZIP/Postal Code
70852
Country
Czech Republic
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna
City
Praha 10
ZIP/Postal Code
10034
Country
Czech Republic
Facility Name
Universitätsklinikum Regensburg
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitaetsmedizin Goettingen
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Universitatsmedizin Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Augenärzte am St. Franziskus-Hospital
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Universitaetsklinikum Muenster
City
Muenster
ZIP/Postal Code
48159
Country
Germany
Facility Name
Knappschaftsklinikum GmbH
City
Sulzbach, Saar
ZIP/Postal Code
66280
Country
Germany
Facility Name
Universitatsklinikum Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Semmelweis Egyetem, Szemészeti Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Bajcsy-Zsilinszky Korhaz, Szemeszet
City
Budapest
ZIP/Postal Code
1106
Country
Hungary
Facility Name
Budapest Retina Associates Kft.
City
Budapest
ZIP/Postal Code
1133
Country
Hungary
Facility Name
Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Ganglion Orvosi Kozpont
City
Pecs
ZIP/Postal Code
7621
Country
Hungary
Facility Name
Csolnoky Ferenc Korhaz, Szemeszeti Osztaly
City
Veszprem
ZIP/Postal Code
8200
Country
Hungary
Facility Name
Hadassah Medical Organization, Hadassah Medical Center, Ein Karem
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center, Beilinson Hospital
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Spitalul Clinic Republican
City
Chisinau
ZIP/Postal Code
MD-2025
Country
Moldova, Republic of
Facility Name
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki
City
Wroclaw
ZIP/Postal Code
50-367
Country
Poland
Facility Name
Med Life SA, Sectia Oftalmologie
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu"
City
Bucuresti
ZIP/Postal Code
020475
Country
Romania
12. IPD Sharing Statement
Citations:
PubMed Identifier
29847672
Citation
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.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1261009&StudyName=A%20Phase%202%2C%20Multi-Center%20Study%20To%20Compare%20The%20Efficacy%20And%20Safety%20Of%20A%20Chemokine%20CCR2/5%20Receptor%20Antagonist%20With%20Ranibizumab%20In%20Adult
Description
To obtain contact information for a study center near you, click here.
Learn more about this trial
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
We'll reach out to this number within 24 hrs