PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
MATISSE
An Open-Label Dose Escalation Study of PF-04523655 (Stratum I) Combined With a Prospective, Randomized, Double-Masked, Multi-Center, Controlled Study (Stratum II) Evaluating the Efficacy and Safety of PF-04523655 Alone and in Combination With Ranibizumab Versus Ranibizumab Alone in Diabetic Macular Edema (MATISSE STUDY)
2 other identifiers
interventional
258
7 countries
51
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2012
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2011
CompletedFirst Posted
Study publicly available on registry
October 4, 2011
CompletedStudy Start
First participant enrolled
February 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2013
CompletedFebruary 23, 2015
February 1, 2015
1.8 years
September 30, 2011
February 3, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Safety and dose-limiting toxicities (Stratum I)
\- To determine the safety and dose-limiting toxicities of a single intravitreal (IVT) injection of PF-04523655 in subjects with low vision
6 months post-injection
Pharmacokinetics (Stratum I)
\- To determine the pharmacokinetics (PK) of a single IVT injection of PF-04523655 in subjects with low vision
6 months post-injection
Safety and tolerability (Stratum II)
\- To evaluate the safety and tolerability of PF-04523655 alone and in combination with ranibizumab in subjects with diabetic macular edema (DME)
30 days after the last injection
Efficacy (Stratum II)
\- To evaluate the ability of PF-04523655 alone and in combination with ranibizumab to improve visual acuity compared to ranibizumab alone in subjects with DME
30 days after the last injection
Secondary Outcomes (1)
Anatomical changes in retina and retinal nerve fiber layer morphology (Stratum II)
30 days after the last injection
Study Arms (4)
PF-04523655 (Stratum II)
EXPERIMENTALStratum II, 6 monthly injections of PF-04523655 only
PF-04523655 and ranibizumab
EXPERIMENTALStratum II, 6 monthly injections of PF-0423655 and ranibizumab administered in combination
ranibizumab
ACTIVE COMPARATORStratum II, 6 monthly IVT injections of ranibizumab only
PF-04523655 (Stratum I)
EXPERIMENTALStratum I
Interventions
PF-04523655 (a small interfering RNA) - a single IVT injection
6 monthly IVT injections of ranibizumab (Stratum II)
6 monthly IVT injections of PF-04523655 (a small interfering RNA)
Eligibility Criteria
You may qualify if:
- Visual acuity in the study eye ≤ 20/200.
- Low visual acuity is the result of an irreversible condition affecting the posterior segment of the study eye.
You may not qualify if:
- History of vitrectomy.
- History of IVT injection in study eye within last 6 months.
- History of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
- History of uveitis or endophthalmitis in either eye.
- Any active inflammatory condition in study eye.
- Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
- Any medical condition, concomitant therapy or previous incisional or laser surgery that, in the opinion of the Investigator, would preclude IVT injection in the study eye.
- Intraocular pressure in either eye ≥25 mmHg on maximal medication.
- Cataract surgery and laser corneal surgery within 3 months prior to dosing in the study eye and all other intraocular surgeries at any time.
- Participation in a concurrent interventional study within 30 days prior to dosing.
- History of diabetes mellitus (Type 1 or Type 2).
- Retinal thickening secondary to the edema caused by diabetes mellitus.
- Best corrected visual acuity (BCVA) of 20/40 or worse and up to 20/320 or better in the study eye at Screening.
- Standard of care treatment for DME can be withheld for at least 90 days after the subject has enrolled in the study (study eye only).
- History of panretinal photocoagulation within 6 months or macular laser photocoagulation within 3 months of prior to dosing in the study eye.
- +14 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Retina Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina Institute of California
Arcadia, California, 91007, United States
Retina-Vitreous Associates
Beverly Hills, California, 90211, United States
Retina Diagnostic Center
Campbell, California, 95008, United States
Retinal Consultants Medical Group, Inc.
Sacramento, California, 95819, United States
Orange County Reina Medical Group
Santa Ana, California, 92705, United States
MedEye Associates
Miami, Florida, 33143, United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Thomas A. Cuilla, MD, PC at Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Eyesight Ophthalmic Services, PA
Portsmouth, New Hampshire, 03801, United States
Retina Vitreous Center
Toms River, New Jersey, 08755, United States
Southeast Clinical Research Associates, LLC
Charlotte, North Carolina, 28210, United States
Black Hills Regioinal Eye Institute
Rapid City, South Dakota, 57701, United States
Tennessee Retina, PC
Nashville, Tennessee, 37203, United States
Retina Research Center
Austin, Texas, 78705, United States
Retinal Consultants of Houston
Houston, Texas, 77030, United States
Valley Retina Institute
McAllen, Texas, 78503, United States
Retinal Consultants of San Antonio
San Antonio, Texas, 78204, United States
Retinal Institute of Virginia
Richmond, Virginia, 23235, United States
University Hospital Ghent
Ghent, Belgium, 9000, Belgium
Brugmann Ziekenhuis
Laken, Belgium, 1020, Belgium
Fakultni nemocnice Brno
Brno, Czech Republic, 62500, Czechia
Fakultní nemocnice Hradec Kralove
Kralove, Czech Republic, 50005, Czechia
Fakultní nemocnice Ostrava
Ostrava, Czech Republic, 70852, Czechia
GEMINI oční centrum, a.s
Zlín, Czech Republic, 76001, Czechia
Augenärzte Gemeinschaftspraxis Ahaus-Gronau-Lingen-Münster-Bad Bentheim
Ahaus, Germany, 48683, Germany
Augenklinik Klinikum Darmstadt
Darmstadt, Germany, 64297, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, 67063, Germany
Klinik und Poliklinik für Augenheilkunde Klinikum rechts der Isar
München, Germany, 81675, Germany
Augenklinik am St. Franziskus-Hospital Muenster
Münster, Germany, 48145, Germany
Soroka University Medical Center
Beersheba, Israel, 84101, Israel
Bnai Zion Medical Center
Haifa, Israel, 31048, Israel
Meir Medical Center
Kfar Saba, Israel, 44281, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel, 52621, Israel
Hadassah Ein Kerem Medical Center
Jerusalem, Israel
Rabin Medical Center
Petah Tikva, Israel
Kaplan Medical Center
Rehovot, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Assaf Harofe Medical Center
Ẕerifin, Israel
Oftalmika
Bydgoszcz, Poland, 85631, Poland
Szpital Specjalistyczny Nr 1 w Bytomiu
Bytom, Poland, 41902, Poland
Profesorskie Centrum Okulistyki, Hipermarket Tesco
Gdansk, Poland, 80809, Poland
Spectrum OOK
Wroclaw, Poland, 51-646, Poland
Southamptom Eye Unit, Southampton Hospital
Shirley, Southampton, SO16 6YD, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Frimley, Surrey, GU16 7UJ, United Kingdom
Eye and Ear Clinicl, The Royal Victoria Hospital
Belfast, United Kingdom, BT12 6BA, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom, BS1 2LX, United Kingdom
St. James University Hospital
Leeds, United Kingdom, LS9 7TF, United Kingdom
Moorfields Eye Hospital
London, United Kingdom, EC1V 2PD, United Kingdom
Royal Hallamshire Hospital, Eye Department
Sheffield, United Kingdom, S10 2JF, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rabia Ozden, MD
Quark Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2011
First Posted
October 4, 2011
Study Start
February 1, 2012
Primary Completion
November 1, 2013
Study Completion
November 1, 2013
Last Updated
February 23, 2015
Record last verified: 2015-02