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: Completed Phase 2 study of Diabetic Macular Edema and Diabetic Retinopathy, sponsored by Quark Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
\- To determine the safety and dose-limiting toxicities of a single intravitreal (IVT) injection of PF-04523655 in subjects with low vision
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 |
What the finished NCT01445899 record still lists
NCT01445899 is an interventional study that assigns participants to a tested intervention. The registered 258 participants enrollment target is mid-sized for trials with a published cap, below the 3,790-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (93% lower).
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 names 20 study sites across 12 states, led by 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.
Where NCT01445899's enrollment target sits among peer trials
258 18th of 63 higher than 46 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03785288 · 258 participants · Phase 3
Vaginal Cuff Brachytherapy Fractionation Study
- NCT04643002 · 258 participants · Phase 1
Isatuximab in Combination With Novel Agents in RRMM - Master Protocol
- NCT04924322 · 258 participants · Phase 2
Catheter-Related Early Thromboprophylaxis With Enoxaparin Studies
- NCT05043012 · 258 participants · NA
Diagnostic Performance Of Non-Endorectal Coil Multiparametric Magnetic Resonance Imaging Of Prostate With Flexible AIR Coil (DoNEMAC Study)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia