PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
Completed · Phase 2
Conditions studied: Choroidal Neovascularization, Diabetic Retinopathy, Diabetic Macular Edema
In brief
This is a two-part study. The first part (Stratum I) is an open-label, dose escalation, safety, tolerability and pharmacokinetic study, where active study drug (PF-04523655) will be given to all patients who participate. Stratum I will determine the maximum tolerated dose and any dose-limiting toxicities. The second part (Stratum II) is a prospectively randomized, multi-center, double-masked, dose ranging study evaluating the efficacy and safety of PF-04523655 alone and in combination with ranibizumab versus ranibizumab alone in patients with DME.
Key facts
- Study ID
- NCT01445899
- Run by
- Quark Pharmaceuticals
- People needed
- 258
- Starts
- 2012-02-01
- Expected to finish
- 2013-11-01
- Last updated by the study team
- 2015-02-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Retina Institute of California — Arcadia, California, United States
- Retina-Vitreous Associates — Beverly Hills, California, United States
- Retina Diagnostic Center — Campbell, California, United States
- Retinal Consultants Medical Group, Inc. — Sacramento, California, United States
- Orange County Reina Medical Group — Santa Ana, California, United States
- MedEye Associates — Miami, Florida, United States
- Center for Retina and Macular Disease — Winter Haven, Florida, United States
- Southeast Retina Center — Augusta, Georgia, United States
- Thomas A. Cuilla, MD, PC at Midwest Eye Institute — Indianapolis, Indiana, United States
- Eyesight Ophthalmic Services, PA — Portsmouth, New Hampshire, United States
- Retina Vitreous Center — Toms River, New Jersey, United States
- Southeast Clinical Research Associates, LLC — Charlotte, North Carolina, United States
- Black Hills Regioinal Eye Institute — Rapid City, South Dakota, United States
- Tennessee Retina, PC — Nashville, Tennessee, United States
- Retina Research Center — Austin, Texas, United States
- Retinal Consultants of Houston — Houston, Texas, United States
- Valley Retina Institute — McAllen, Texas, United States
- Retinal Consultants of San Antonio — San Antonio, Texas, United States
- Retinal Institute of Virginia — Richmond, Virginia, United States
- University Hospital Ghent — Ghent, Belgium, Belgium
- Brugmann Ziekenhuis — Laken, Belgium, Belgium
- Fakultni nemocnice Brno — Brno, Czech Republic, Czechia
- Fakultní nemocnice Hradec Kralove — Kralove, Czech Republic, Czechia
- Fakultní nemocnice Ostrava — Ostrava, Czech Republic, Czechia
- Retina Consultants of Arizona — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.