Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01445899 · ClinicalTrials.gov registry record · Phase 2
PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
A Phase 2 study of Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Quark Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 258
- Enrollment target
- 20
- Study locations
NCT01445899 is a Phase 2 study of Diabetic Macular Edema and Diabetic Retinopathy that has completed, run by Quark Pharmaceuticals. The registered enrollment target is 258 participants, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states.
The verdict
NCT01445899, a Phase 2 study of Diabetic Macular Edema and Diabetic Retinopathy, has completed, sponsored by Quark Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 258 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 258 participants |
| Start Date | 2012-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 2 |
Interested in This Trial?
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, categorized as Phase 2. The registered enrollment target is 258 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower). The listed sponsor is Quark Pharmaceuticals, which has 14 total studies on file at ClinicalTrials.gov.
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.
NCT01445899 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Texas, Florida.
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.
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).
Who is sponsoring clinical trial NCT01445899?
This trial is sponsored by Quark Pharmaceuticals, which has 14 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
-
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
RECRUITING · Phase 2
-
A Pivotal Safety and Efficacy Study of OCS-01 Eye Drops in Participants With Diabetic Macular Edema (DIAMOND 1)
ACTIVE NOT RECRUITING · Phase 2
-
4D-150 in Patients With Diabetic Macular Edema
ACTIVE NOT RECRUITING · Phase 2
-
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME
ACTIVE NOT RECRUITING · Phase 2
-
Evaluation of Tonabersat for DME
ACTIVE NOT RECRUITING · Phase 2
-
Study of the Intravitreal Plasma Kallikrein Inhibitor, KVD001, in Subjects With Center-involving Diabetic Macular Edema (ciDME)
COMPLETED · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.