Phase II Open Label Multicenter Study For Age Related Macular Degeneration Comparing PF-04523655 Versus Lucentis In The Treatment Of Subjects With CNV (MONET Study).
NCT ID: NCT00713518
Last Updated: 2012-10-12
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
152 participants
INTERVENTIONAL
2009-11-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm 1 ranibizumab
0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12
0.5 mg ranibizumab
Arm 2 ranibizumab and PF-04523655
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg PF-04523655 given by intravitreal injection every 2 weeks from Week 4 to Week 12
0.5 mg ranibizumab
3 mg PF-04523655
Arm 3 ranibizumab and PF-04523655
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg PF-04523655 given by intravitreal injection evey 4 weeks to Week 12
0.5 mg ranibizumab
1 mg PF-04523655
Arm 4 ranibizumab and PF-04523655
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 3 mg of PF-04523655 given by intravitreal injection every 4 weeks from Week 4 to Week 12
0.5 mg ranibizumab
3 mg PF-04523655
Arm 5 ranibizumab and PF-04523655
0.5 mg ranibizumab given by intravitreal injection at baseline followed by 1 mg of PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12
0.5 mg ranibizumab
1 mg PF-04523655
Interventions
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0.5 mg ranibizumab
3 mg PF-04523655
1 mg PF-04523655
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The total area of CNV (including both classic and occult components) encompassed within the lesion must be 50% or more of the total lesion area.
* The total lesion size ≤12 disc areas.
* Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
* Best corrected visual acuity score in the fellow eye of 20/400 or better (letter score of ≥19) at the Screening Visit. Note: Only one eye will be treated (study eye) through the duration of the study. In the event both eyes are eligible for study entry the study eye should be selected by the investigator and subject. The non-study eye may be treated with an approved AMD therapy
* Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT.
Exclusion Criteria
* Previous subfoveal focal laser photocoagulation in the study eye
* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline
* History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye
* Previous participation in any studies with investigational drugs or treatments administered 1 month preceding Baseline visit such as systemic glucocorticoids, ocular or periocular steroids (eg, triamcinolone, anecortave acetate), anti-angiogenic drugs such as pegaptanib (Macugen), ranibizumab (Lucentis), bevacizumab (Avastin) in the study eye
* Subretinal hemorrhage in the study eye that involves the fovea, if the size of the hemorrhage is either 50% or more of the total lesion area or 1 or more disc areas in size
* CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia
* Presence of subfoveal scarring
* Retinal pigment epithelial tear involving the macula in the study eye
50 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Quark Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
San Francisco, California, United States
Pfizer Investigational Site
Fort Myers, Florida, United States
Pfizer Investigational Site
Winter Haven, Florida, United States
Pfizer Investigational Site
Augusta, Georgia, United States
Pfizer Investigational Site
Indianapolis, Indiana, United States
Pfizer Investigational Site
Cleveland, Ohio, United States
Pfizer Investigational Site
Austin, Texas, United States
Pfizer Investigational Site
Linz, , Austria
Pfizer Investigational Site
Vienna, , Austria
Pfizer Investigational Site
Glostrup Municipality, , Denmark
Pfizer Investigational Site
Hong Kong, , Hong Kong
Pfizer Investigational Site
Ahmedabad, Gujarat, India
Pfizer Investigational Site
Navrangpura, Ahmedabad, Gujarat, India
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India
Pfizer Investigational Site
New Delhi, , India
Pfizer Investigational Site
Kfar Saba, , Israel
Pfizer Investigational Site
Petah Tikva, , Israel
Pfizer Investigational Site
Tel Aviv, , Israel
Pfizer Investigational Site
Tel Litwinsky, , Israel
Pfizer Investigational Site
Ẕerifin, , Israel
Pfizer Investigational Site
Makati City, , Philippines
Pfizer Investigational Site
Manila, , Philippines
Pfizer Investigational Site
Quezon City, , Philippines
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Seoul, , South Korea
Pfizer Investigational Site
Alicante, Alicante, Spain
Pfizer Investigational Site
Barcelona, Barcelona, Spain
Pfizer Investigational Site
Valencia, Valencia, Spain
Pfizer Investigational Site
Taipei, , Taiwan
Pfizer Investigational Site
Ankara, , Turkey (Türkiye)
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B0451001
Identifier Type: -
Identifier Source: org_study_id