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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

NCT01994291 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 199

Last updated 2016-10-17

Study results available
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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.

Conditions

  • Macular Edema, Diabetic

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

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

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01994291 on ClinicalTrials.gov