Status:
COMPLETED
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).
Lead Sponsor:
Quark Pharmaceuticals
Collaborating Sponsors:
Pfizer
Conditions:
Age Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.
Eligibility Criteria
Inclusion
- Males and females age 50 years or older with active primary or recurrent subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Active CNV is defined as any leakage detected on FFA or OCT. Note: Female subjects 50- 60 years of age must be amenorrheic for at least 2 years and have a serum FSH level within the laboratory reference range for postmenopausal women
- 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
- Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT00713518
Start Date
November 1 2009
End Date
July 1 2011
Last Update
October 12 2012
Active Locations (31)
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1
Pfizer Investigational Site
San Francisco, California, United States, 94143
2
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
3
Pfizer Investigational Site
Winter Haven, Florida, United States, 33880
4
Pfizer Investigational Site
Augusta, Georgia, United States, 30909