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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

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Retina Research Institute, LLC
Phoenix, Arizona, 85014 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Diabetic Macular Edema
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01994291
Pfizer
Terminated
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

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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
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Macular Edema, Diabetic
  • 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
  • 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

  • Drug: PF-04634817
    Four 50mg tablets PF-04634817 once a day for 12 weeks.
  • Drug: Masked Sham Therapy
    Empty, needle-less syringe is used by the unmasked team once a month.
  • Active Comparator: 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.
    Interventions:
    • Drug: Ranibizumab
    • Drug: Placebo
  • Experimental: Arm 2
    Oral PF-04634817 200 mg, once daily plus a masked sham therapy (given monthly).
    Interventions:
    • Drug: PF-04634817
    • Drug: Masked Sham Therapy
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
199
August 2015
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   Germany,   Hungary,   Israel,   Moldova, Republic of,   Poland,   Romania,   United States
 
 
NCT01994291
B1261009
2013-003147-27 ( EudraCT Number )
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2016

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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