Phase II Open Label Multicenter Study For Age Related Mac... | NCT00713518

NCT00713518

Status Module

Name	Class
Pfizer	INDUSTRY

Oversight Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1 ranibizumab	Active Comparator	0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12	Drug: 0.5 mg ranibizumab
Arm 2 ranibizumab and PF-04523655	Experimental	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	Drug: 0.5 mg ranibizumab Drug: 3 mg PF-04523655
Arm 3 ranibizumab and PF-04523655	Experimental	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	Drug: 0.5 mg ranibizumab Drug: 1 mg PF-04523655
Arm 4 ranibizumab and PF-04523655	Experimental	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	Drug: 0.5 mg ranibizumab Drug: 3 mg PF-04523655
Arm 5 ranibizumab and PF-04523655	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
0.5 mg ranibizumab	Drug		Arm 1 ranibizumab Arm 2 ranibizumab and PF-04523655 Arm 3 ranibizumab and PF-04523655 Arm 4 ranibizumab and PF-04523655 Arm 5 ranibizumab and PF-04523655

Outcomes Module

Measure	Description	Time Frame
Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16		Week 16

Secondary Outcomes

Measure	Description	Time Frame
Percent of subjects gaining >/=15 letters in the best corrected visual acuity score at 16 weeks compared to Baseline, as measured using the ETDRS protocol		Week 16
Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Criteria:

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

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		San Francisco	California	94143	United States
Pfizer Investigational Site

ID	Term
D000069579	Ranibizumab
C576360	PF-04523655

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins