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COMPLETED Phase 2

PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)

NCT01445899 · View on ClinicalTrials.gov ↗

Study Summary

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.

Interventions

  • DRUG ranibizumab
  • DRUG PF-04523655 (Stratum I)
  • DRUG PF-04523655 (Stratum II)

Study Locations (20)

California

  • Retina Institute of California — Arcadia
  • Retina-Vitreous Associates — Beverly Hills
  • Retina Diagnostic Center — Campbell
  • Retinal Consultants Medical Group, Inc. — Sacramento
  • Orange County Reina Medical Group — Santa Ana

Texas

  • Retina Research Center — Austin
  • Retinal Consultants of Houston — Houston
  • Valley Retina Institute — McAllen
  • Retinal Consultants of San Antonio — San Antonio

Florida

  • MedEye Associates — Miami
  • Center for Retina and Macular Disease — Winter Haven

Arizona

  • Retina Consultants of Arizona — Phoenix

Georgia

  • Southeast Retina Center — Augusta

Indiana

  • Thomas A. Cuilla, MD, PC at Midwest Eye Institute — Indianapolis

New Hampshire

  • Eyesight Ophthalmic Services, PA — Portsmouth

New Jersey

  • Retina Vitreous Center — Toms River

Trial Details

FieldValue
Enrollment Target 258 participants
Start Date 2012-02
Est. Completion 2013-11
Phase Phase 2

Sponsor

Quark Pharmaceuticals

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01445899

The ClinicalTrials.gov registry entry for NCT01445899 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Quark Pharmaceuticals, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 3 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 3 interventions — of which ranibizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01445899 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Texas, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01445899 about?

NCT01445899 is a clinical study titled "PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)". 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 toxic...

What is the current status of trial NCT01445899?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 258 participants. The study started on 2012-02. Estimated completion is 2013-11.

What conditions does trial NCT01445899 study?

This clinical trial studies the following conditions: Diabetic Macular Edema, Diabetic Retinopathy, Choroidal Neovascularization. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01445899?

The interventions under investigation include: ranibizumab (DRUG), PF-04523655 (Stratum I) (DRUG), PF-04523655 (Stratum II) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01445899?

This trial is sponsored by Quark Pharmaceuticals, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01445899 being conducted?

This trial has 20 study locations across Arizona, California, Florida, Georgia, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial