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

NCT ID: NCT01994291

Last Updated: 2016-10-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 199 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-08-31

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.

Conditions

Macular Edema, Diabetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Arm 1

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.

Group Type: ACTIVE_COMPARATOR

Ranibizumab

Intervention Type: DRUG

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

Intervention Type: DRUG

Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.

Dose is 4 tablets each day for 12 weeks

Arm 2

Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).

Group Type: EXPERIMENTAL

PF-04634817

Intervention Type: DRUG

Four 50mg tablets PF-04634817 once a day for 12 weeks.

Masked Sham Therapy

Intervention Type: DRUG

Empty, needle-less syringe is used by the unmasked team once a month.

Interventions

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

Intervention Type: DRUG

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

Intervention Type: DRUG

PF-04634817

Four 50mg tablets PF-04634817 once a day for 12 weeks.

Intervention Type: DRUG

Masked Sham Therapy

Empty, needle-less syringe is used by the unmasked team once a month.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Retina Research Institute, LLC

Phoenix, Arizona, United States

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 Vitreous Consultants

Pittsburgh, Pennsylvania, United States

Associates in Ophthalmology Ltd

West Mifflin, Pennsylvania, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Brain B.Berger,MD,PA

Austin, Texas, United States

Retina Research Center

Austin, Texas, United States

Retina Consultants of Houston, PA

Houston, Texas, United States

Medical Center Ophthalmology Associates

San Antonio, Texas, United States

Rocky Mountain Retina Consultants

Salt Lake City, Utah, United States

MC Comac Medical

Sofia, , Bulgaria

Fakultní nemocnice Hradec Králové, Ocni klinika

Hradec Králové, , Czechia

Fakultní nemocnice Hradec Králové, Nemocnicni lekarna

Hradec Králové, , Czechia

Fakultni nemocnice Ostrava, lekarna

Ostrava - Poruba, , Czechia

Fakultni nemocnice Ostrava, Ocni klinika

Ostrava - Poruba, , Czechia

Fakultni nemocnice Kralovske Vinohrady, Oftalmologicka klinika

Prague, , Czechia

Fakultni nemocnice Kralovske Vinohrady, Ustavni lekarna

Prague, , Czechia

Universitätsklinikum Regensburg

Regensburg, Bavaria, Germany

Universitaetsklinikum Muenster

Münster, Germany, Germany

Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin

Berlin, , Germany

Universitaetsmedizin Goettingen

Göttingen, , Germany

Universitatsmedizin Mainz

Mainz, , Germany

Augenärzte am St. Franziskus-Hospital

Münster, , Germany

Knappschaftsklinikum GmbH

Sulzbach, , Germany

Universitatsklinikum Tubingen

Tübingen, , Germany

Semmelweis Egyetem, Szemészeti Klinika

Budapest, , Hungary

Bajcsy-Zsilinszky Korhaz, Szemeszet

Budapest, , Hungary

Budapest Retina Associates Kft.

Budapest, , Hungary

Debreceni Egyetem Orvos- es Egeszsegtudomanyi Centrum, Szemklinika

Debrecen, , Hungary

Ganglion Orvosi Kozpont

Pécs, , Hungary

Csolnoky Ferenc Korhaz, Szemeszeti Osztaly

Veszprém, , Hungary

Hadassah Medical Organization, Hadassah Medical Center, Ein Karem

Jerusalem, , Israel

Meir Medical Center

Kfar Saba, , Israel

Rabin Medical Center, Beilinson Hospital

Petah Tikva, , Israel

Kaplan Medical Center

Rehovot, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Spitalul Clinic Republican

Chisinau, , Moldova

Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza Radeckiego We Wrocławiu, Klinika Okulistyki

Wroclaw, , Poland

Med Life SA, Sectia Oftalmologie

Bucharest, , Romania

Institutul National de Diabet, Nutritie si Boli Metabolice "N.C.Paulescu"

Bucharest, , Romania

Countries

United States; Bulgaria; Czechia; Germany; Hungary; Israel; Moldova; Poland; Romania

References

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.

Reference Type: DERIVED

PMID: 29847672 (View on PubMed)

Related Links

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

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Other Identifiers

2013-003147-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

B1261009

Identifier Type: -

Identifier Source: org_study_id