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).
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Quark Pharmaceuticals
With
Pfizer
Age
50–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | 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).
