Clinical trial NCT00713518: 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).
Official title: 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Keywords: AMD Age Related Macular Degeneration Choroidal Neovascularization Monet
Lead sponsor: Quark Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-07-11
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16
timeFrame: Week 16
Secondary outcomes:
measure: 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
timeFrame: Week 16
measure: Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol
timeFrame: Week 16
measure: Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported
timeFrame: Week 48
measure: Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT
timeFrame: Week 16
measure: Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported
timeFrame: Week 48
measure: Change from Baseline in lesion size on FFA at Week 16
timeFrame: Week 16
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Pfizer Investigational Site
state: California
city: Fort Myers
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Winter Haven
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Augusta
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Linz
country: Austria
facility: Pfizer Investigational Site
city: Wien
country: Austria
facility: Pfizer Investigational Site
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Hong Kong
country: Hong Kong
facility: Pfizer Investigational Site
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Navrangpura, Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: New Delhi
country: India
facility: Pfizer Investigational Site
city: Kfar Saba
country: Israel
facility: Pfizer Investigational Site
city: Petah Tikva
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
city: Tel Hashomer
country: Israel
facility: Pfizer Investigational Site
city: Zerifin
country: Israel
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Makati City
country: Philippines
facility: Pfizer Investigational Site
city: Manila
country: Philippines
facility: Pfizer Investigational Site
city: Quezon City
country: Philippines
facility: Pfizer Investigational Site
city: Alicante
country: Spain
facility: Pfizer Investigational Site
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Valencia
country: Spain
facility: Pfizer Investigational Site
city: Taipei
country: Taiwan
facility: Pfizer Investigational Site
city: Ankara
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: