drugset / Trial / NCT01994291

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

Phase 2 Terminated 199 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2013-11
Primary completion
2015-08
Completion
2015-08

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-04634817 Small molecule 200 mg Oral
Comparator Ranibizumab Monoclonal antibody 0.3 mg Intravitreal
Comparator Ranibizumab Monoclonal antibody 0.5 mg Intravitreal