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).

Age Related Macular Degeneration Clinical Trial

— MONET  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00713518
• Other study ID #: B0451001
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2008
• Last updated: October 10, 2012
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2012
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: July 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration

Intervention

Drug:
• 0.5 mg ranibizumab

• 3 mg PF-04523655

• 1 mg PF-04523655

Locations

Country	Name	City	State
Austria	Pfizer Investigational Site	Linz
Austria	Pfizer Investigational Site	Wien
Denmark	Pfizer Investigational Site	Glostrup
Hong Kong	Pfizer Investigational Site	Hong Kong
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Coimbatore	Tamil Nadu
India	Pfizer Investigational Site	Navrangpura, Ahmedabad	Gujarat
India	Pfizer Investigational Site	New Delhi
Israel	Pfizer Investigational Site	Kfar Saba
Israel	Pfizer Investigational Site	Petah Tikva
Israel	Pfizer Investigational Site	Tel Aviv
Israel	Pfizer Investigational Site	Tel Hashomer
Israel	Pfizer Investigational Site	Zerifin
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Philippines	Pfizer Investigational Site	Makati City
Philippines	Pfizer Investigational Site	Manila
Philippines	Pfizer Investigational Site	Quezon City
Spain	Pfizer Investigational Site	Alicante
Spain	Pfizer Investigational Site	Barcelona
Spain	Pfizer Investigational Site	Valencia
Taiwan	Pfizer Investigational Site	Taipei
Turkey	Pfizer Investigational Site	Ankara
United States	Pfizer Investigational Site	Augusta	Georgia
United States	Pfizer Investigational Site	Austin	Texas
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Fort Myers	Florida
United States	Pfizer Investigational Site	Indianapolis	Indiana
United States	Pfizer Investigational Site	San Francisco	California
United States	Pfizer Investigational Site	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Quark Pharmaceuticals	Pfizer

Countries where clinical trial is conducted

United States,  Austria,  Denmark,  Hong Kong,  India,  Israel,  Korea, Republic of,  Philippines,  Spain,  Taiwan,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16		Week 16	Yes
Secondary	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	Yes
Secondary	Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol		Week 16	Yes
Secondary	Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported		Week 48	Yes
Secondary	Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT		Week 16	Yes
Secondary	Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported		Week 48	Yes
Secondary	Change from Baseline in lesion size on FFA at Week 16		Week 16	Yes

External Links

•   To obtain contact information for a study center near you, click here.