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

Macular Edema, Diabetic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01994291
• Other study ID #: B1261009
• Secondary ID: 2013-003147-27
• Status: Terminated
• Phase: Phase 2
• First received: November 8, 2013
• Last updated: October 8, 2015
• Start date: November 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 212
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Macular Edema, Diabetic

Intervention

Drug:
• Ranibizumab
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
• Placebo
Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817. Dose is 4 tablets each day for 12 weeks
• PF-04634817
Four 50mg tablets PF-04634817 once a day for 12 weeks.
• Masked Sham Therapy
Empty, needle-less syringe is used by the unmasked team once a month.

Locations

Country	Name	City	State
Bulgaria	MC Comac Medical	Sofia
Czech Republic	Fakultní nemocnice Hradec Králové, Ocni klinika	Hradec Kralove
Czech Republic	Fakultni nemocnice Ostrava	Ostrava - Poruba
Czech Republic	Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika	Praha 10
Germany	Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin	Berlin
Germany	Universitaetsmedizin Goettingen	Goettingen
Germany	Universitatsmedizin Mainz	Mainz
Germany	Augenärzte am St. Franziskus-Hospital	Muenster
Germany	Universitaetsklinikum Muenster	Muenster
Germany	Universitätsklinikum Regensburg	Regensburg	Bavaria
Germany	Knappschaftsklinikum GmbH	Sulzbach (Saar)
Germany	Universitatsklinikum Tubingen	Tubingen
Hungary	Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Budapest Retina Associates Kft.	Budapest
Hungary	Semmelweis Egyetem, Szemészeti Klinika	Budapest
Hungary	University of Debrecen Medical and Health Science	Debrecen
Hungary	Csolnoky Ferec County Hospital Department of Opht	Korhaz u.1
Hungary	Ganglion Medical Center	Pecs
Israel	Hadassah Medical Organization	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Israel	Kaplan Medical Center	Rehovot
Israel	Tel Aviv Sourasky Medical Center	Tel Aviv
Moldova, Republic of	Spitalul Clinic Republican	Chisinau
Poland	Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wroclawiu, Klinika Okulistyki	Wroclaw
Romania	Institutul National de Diabet	Bucuresti
Romania	Institutul National de Diabet Nutritie si Boli Me	Bucuresti
United States	Retina Institute of California	Arcadia	California
United States	Southeast Retina Center, PC	Augusta	Georgia
United States	Retina Research Center	Austin	Texas
United States	Retina Vitreous Associates Medical Group	Beverly Hills	California
United States	Tufts Medical Center	Boston	Massachusetts
United States	Retinal Diagnostic Center	Campbell	California
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 Consultants of Houston	Houston	Texas
United States	Midwest Eye Institute	Indianapolis	Indiana
United States	TLC Eyecare and Laser Centers	Jackson	Michigan
United States	Retina Associates of Orange County	Laguna Hills	California
United States	Bascom Palmer Eye Institute	Miami	Florida
United States	New England Retina Associates	New London	Connecticut
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Southern California Desert Retina Consultants	Palm Desert	California
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	Retina Vitreous Consultants	Pittsburgh	Pennsylvania
United States	Fort Lauderdale Eye Institute	Plantation	Florida
United States	Black Hills Regional Eye Institute	Rapid City	South Dakota
United States	Associated Retinal Consultants, PC	Royal Oak	Michigan
United States	Rocky Mountain Retina Consultants	Salt Lake City	Utah
United States	Medical Center Ophthalmology Associates	San Antonio	Texas
United States	Retina Centers, P.C.	Tucson	Arizona
United States	Associates in Ophthalmology Ltd	West Mifflin	Pennsylvania
United States	Center for Retina and Macular Disease	Winter Haven	Florida
United States	Retina Associates of Cleveland	Youngstown	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Bulgaria,  Czech Republic,  Germany,  Hungary,  Israel,  Moldova, Republic of,  Poland,  Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Change from Baseline in the Best Corrected Visual Acuity Score		Baseline, 12 weeks	No
Secondary	Proportion of participants gaining 15 ETDRS letters in BCVA from baseline		Baseline, 12 Weeks	No
Secondary	Mean changes in central subfield retinal thickness from baseline as assessed by optical coherence tomography (OCT)		Baseline, 12 Weeks	No
Secondary	Mean changes in the area of fluorescein leakage from baseline by scheduled study visit as assessed by fluorescein angiography (FA)		Baseline, 12 Weeks	No
Secondary	Mean change in steps of diabetic retinopathy (ETDRS severity scale) from baseline as assessed by digital fundus photography (FP)		Baseline, 12 Weeks	No
Secondary	The systemic exposure of PF-04634817 in participants with diabetes and macular edema	PK samples will be taken pre-dose and 2 hours (+15 mins) post-dose for all randomized subjects from Visit 2 to Visit 4 and during Visit 5. The systemic exposure of PF-04634817 will be evaluated at the above mentioned time points. Summary statistics for exposure at different time points will be presented.	12 Weeks	No

External Links

•   To obtain contact information for a study center near you, click here.