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).

NCT00713518 | Completed Phase 2

• 1 other identifier: B0451001
• Study Type: interventional
• Target: 152
• Locations: 11 countries
• Sites: 31

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.

Conditions

Age Related Macular Degeneration

Keywords

AMD Age Related Macular Degeneration Choroidal Neovascularization Monet

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• 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

  Week 16

• Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported

  Week 48

• Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT

  Week 16

• Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported

  Week 48

Study Arms (5)

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

Drug: 0.5 mg ranibizumab; Drug: 1 mg PF-04523655

Interventions

0.5 mg ranibizumab DRUG

Also known as: Lucentis

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

3 mg PF-04523655 DRUG

Arm 2 ranibizumab and PF-04523655; Arm 4 ranibizumab and PF-04523655

1 mg PF-04523655 DRUG

Arm 3 ranibizumab and PF-04523655; Arm 5 ranibizumab and PF-04523655

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 qualify 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

Sponsors & Collaborators

• Quark Pharmaceuticals: lead
• Pfizer: collaborator

Study Sites (31)

Pfizer Investigational Site

San Francisco, California, 94143, United States

Location

Pfizer Investigational Site

Fort Myers, Florida, 33912, United States

Location

Pfizer Investigational Site

Winter Haven, Florida, 33880, United States

Location

Pfizer Investigational Site

Augusta, Georgia, 30909, United States

Location

Pfizer Investigational Site

Indianapolis, Indiana, 46290, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Linz, A-4021, Austria

Location

Pfizer Investigational Site

Vienna, A-1030, Austria

Location

Pfizer Investigational Site

Glostrup Municipality, 2600, Denmark

Location

Pfizer Investigational Site

Hong Kong, 0, Hong Kong

Location

Pfizer Investigational Site

Ahmedabad, Gujarat, 380 004, India

Location

Pfizer Investigational Site

Navrangpura, Ahmedabad, Gujarat, 380009, India

Location

Pfizer Investigational Site

Coimbatore, Tamil Nadu, 641014, India

Location

Pfizer Investigational Site

New Delhi, 110029, India

Location

Pfizer Investigational Site

Kfar Saba, 44281, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Tel Aviv, 64239, Israel

Location

Pfizer Investigational Site

Tel Litwinsky, 52621, Israel

Location

Pfizer Investigational Site

Ẕerifin, 70300, Israel

Location

Pfizer Investigational Site

Makati City, 1200, Philippines

Location

Pfizer Investigational Site

Manila, 1008, Philippines

Location

Pfizer Investigational Site

Quezon City, 1113, Philippines

Location

Pfizer Investigational Site

Seoul, 110-744, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Alicante, Alicante, 03016, Spain

Location

Pfizer Investigational Site

Barcelona, Barcelona, 08035, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46014, Spain

Location

Pfizer Investigational Site

Taipei, 100, Taiwan

Location

Pfizer Investigational Site

Ankara, 06100, Turkey (Türkiye)

Location

Related Links

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

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; PF-04523655

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2008
• First Posted: July 11, 2008
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: July 1, 2011
• Last Updated: October 12, 2012

Record last verified: 2012-10

Locations

HK (1); US (7); AU (2); DK (1); TW (1); KR (3); IL (5); PH (3); TU (1); IN (4); ES (3)