PF-04523655 Dose Escalation Study, and Evaluation of PF-04523655 With/Without Ranibizumab in Diabetic Macular Edema (DME)
NCT ID: NCT01445899
Last Updated: 2015-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
258 participants
INTERVENTIONAL
2012-02-29
2013-11-30
Brief Summary
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Detailed Description
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1. Stratum I will enroll up to 24 subjects with low vision, inclusive of possible intermediate doses, in up to 4 cohorts of 3-6 evaluable subjects.
2. Stratum II will enroll approximately 240 subjects with DME 1:1:1:1 in up to 4 cohorts of 60 evaluable subjects.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PF-04523655 (Stratum II)
Stratum II, 6 monthly injections of PF-04523655 only
PF-04523655 (Stratum II)
6 monthly IVT injections of PF-04523655 (a small interfering RNA)
PF-04523655 and ranibizumab
Stratum II, 6 monthly injections of PF-0423655 and ranibizumab administered in combination
ranibizumab
6 monthly IVT injections of ranibizumab (Stratum II)
PF-04523655 (Stratum II)
6 monthly IVT injections of PF-04523655 (a small interfering RNA)
ranibizumab
Stratum II, 6 monthly IVT injections of ranibizumab only
ranibizumab
6 monthly IVT injections of ranibizumab (Stratum II)
PF-04523655 (Stratum I)
Stratum I
PF-04523655 (Stratum I)
PF-04523655 (a small interfering RNA) - a single IVT injection
Interventions
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PF-04523655 (Stratum I)
PF-04523655 (a small interfering RNA) - a single IVT injection
ranibizumab
6 monthly IVT injections of ranibizumab (Stratum II)
PF-04523655 (Stratum II)
6 monthly IVT injections of PF-04523655 (a small interfering RNA)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Low visual acuity is the result of an irreversible condition affecting the posterior segment of the study eye.
1. History of diabetes mellitus (Type 1 or Type 2).
2. Retinal thickening secondary to the edema caused by diabetes mellitus.
3. Best corrected visual acuity (BCVA) of 20/40 or worse and up to 20/320 or better in the study eye at Screening.
4. 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).
Exclusion Criteria
2. History of IVT injection in study eye within last 6 months.
3. History of vitreous hemorrhage, retinal detachment, or invasive trauma in study eye.
4. History of uveitis or endophthalmitis in either eye.
5. Any active inflammatory condition in study eye.
6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
7. 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.
8. Intraocular pressure in either eye ≥25 mmHg on maximal medication.
9. Cataract surgery and laser corneal surgery within 3 months prior to dosing in the study eye and all other intraocular surgeries at any time.
10. Participation in a concurrent interventional study within 30 days prior to dosing.
1. History of panretinal photocoagulation within 6 months or macular laser photocoagulation within 3 months of prior to dosing in the study eye.
2. Any IVT injection therapy performed in the study eye within 3 months prior to dosing.
3. Iris neovascularization, vitreous hemorrhage, tractional retinal detachment, vitreomacular traction, clinically significant epiretinal membrane or clinically significant preretinal fibrosis involving the macula in the study eye.
4. History of vitreoretinal surgery or incisional glaucoma surgery in the study eye.
5. Prior intraocular surgery or corneal laser surgery, performed within 3 months prior to dosing in the study eye.
6. Received any drugs known to cause optic nerve or retinal toxicity within 14 days prior to dosing.
7. High risk (in the opinion of the Investigator) proliferative diabetic retinopathy (PDR) in the study eye.
8. Current infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
9. Monocular subjects.
10. History of idiopathic or autoimmune uveitis in either eye.
11. Aphakia or absence of the posterior capsule in the study eye.
12. Structural damage to the center of the macula in the study eye likely to preclude improvement in visual acuity following the resolution of macular edema.
13. Uncontrolled glaucoma in either eye.
14. Spherical equivalent of the refractive error in the study eye of more than -8 diopters myopia.
15. Use of corticosteroids that, in the Investigator's opinion, may change the status of the subject's diabetic retinopathy in the study eye.
18 Years
ALL
No
Sponsors
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Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Rabia Ozden, MD
Role: STUDY_DIRECTOR
Quark Pharmaceuticals
Locations
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Retina Consultants of Arizona
Phoenix, Arizona, United States
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
GEMINI oční centrum, a.s
Zlín, Czech Republic, Czechia
Augenärzte Gemeinschaftspraxis Ahaus-Gronau-Lingen-Münster-Bad Bentheim
Ahaus, Germany, Germany
Augenklinik Klinikum Darmstadt
Darmstadt, Germany, Germany
Klinikum der Stadt Ludwigshafen
Ludwigshafen, Germany, Germany
Klinik und Poliklinik für Augenheilkunde Klinikum rechts der Isar
München, Germany, Germany
Augenklinik am St. Franziskus-Hospital Muenster
Münster, Germany, Germany
Soroka University Medical Center
Beersheba, Israel, Israel
Bnai Zion Medical Center
Haifa, Israel, Israel
Meir Medical Center
Kfar Saba, Israel, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, Israel, 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, Poland
Szpital Specjalistyczny Nr 1 w Bytomiu
Bytom, Poland, Poland
Profesorskie Centrum Okulistyki, Hipermarket Tesco
Gdansk, Poland, Poland
Spectrum OOK
Wroclaw, Poland, Poland
Southamptom Eye Unit, Southampton Hospital
Shirley, Southampton, United Kingdom
Frimley Park Hospital NHS Foundation Trust
Frimley, Surrey, United Kingdom
Eye and Ear Clinicl, The Royal Victoria Hospital
Belfast, United Kingdom, United Kingdom
Bristol Eye Hospital
Bristol, United Kingdom, United Kingdom
St. James University Hospital
Leeds, United Kingdom, United Kingdom
Moorfields Eye Hospital
London, United Kingdom, United Kingdom
Royal Hallamshire Hospital, Eye Department
Sheffield, United Kingdom, United Kingdom
Countries
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Other Identifiers
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2011-004157-66
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
QRK202
Identifier Type: -
Identifier Source: org_study_id
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