PHASE II OPen Label, MULTICENTER, PROSPECTIVE, RANDOMIZED, AGE RELATED MACULAR DEGENERATION, COMPARATOR controlled, STUDY evaluating PF 04523655 VERSUS RANIBIZUMAB IN the treatment of SUBJECTS WITH CHOROIDAL NEOVASCULARIZATION (MONet study)
- Conditions
- Health Condition 1: null- Age Related Macular Degeneration
- Registration Number
- CTRI/2009/091/000385
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 150
Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
1.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
2.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.
3 The total lesion size ≤12 disc areas.
4 Best corrected visual acuity using ETDRS protocol of 20/40 to 20/320 (letter score ≤73) in the study eye at the screening visit.
5 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
6. Subject has retinal central subfield thickness ≥250µm measured using Stratus OCT.
1. Prior treatment with verteporfin photodynamic therapy, external-beam radiation therapy, or transpupillary thermotherapy in the study eye
2. Previous subfoveal focal laser photocoagulation in the study eye
3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month preceding Baseline
4. History of vitrectomy, submacular surgery or other surgical intervention for AMD in the study eye
5. 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
6. 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
7. CNV in either eye of other etiology, eg, ocular histoplasmosis, trauma, or pathologic myopia
8. Presence of subfoveal scarring
9. Retinal pigment epithelial tear involving the macula in the study eye
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol at Week 16Timepoint: Week 16
- Secondary Outcome Measures
Name Time Method 1. Percent of subjects gaining >/=15 letters in the best corrected visual acuity score at 16 weeks compared to Baseline, as measured using the ETDRS protocolTimepoint: Week 16;2.Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocolTimepoint: Week 16;3.Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reportedTimepoint: week 48;4.Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCTTimepoint: week 16;5.Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reportedTimepoint: week 48;6.Change from Baseline in lesion size on FFA at Week 16Timepoint: week 16