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). (MONET)

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).

The aim of the study is to evaluate whether PF-04523655 is effective in the treatment of neovascular/wet AMD and at which dose.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Drug: 0.5 mg ranibizumab; Drug: 3 mg PF-04523655; Drug: 1 mg PF-04523655

• Study Type: Interventional
• Enrollment (Actual): 152
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Linz, Austria, A-4021
    • Pfizer Investigational Site
  • Wien, Austria, A-1030
    • Pfizer Investigational Site
• Denmark
  • Glostrup, Denmark, 2600
    • Pfizer Investigational Site
• Hong Kong
  • Hong Kong, Hong Kong
    • Pfizer Investigational Site
• India
  • New Delhi, India, 110029
    • Pfizer Investigational Site
  • Gujarat
    • Ahmedabad, Gujarat, India, 380 004
      • Pfizer Investigational Site
    • Navrangpura, Ahmedabad, Gujarat, India, 380009
      • Pfizer Investigational Site
  • Tamil Nadu
    • Coimbatore, Tamil Nadu, India, 641014
      • Pfizer Investigational Site
• Israel
  • Kfar Saba, Israel, 44281
    • Pfizer Investigational Site
  • Petah Tikva, Israel, 49100
    • Pfizer Investigational Site
  • Tel Aviv, Israel, 64239
    • Pfizer Investigational Site
  • Tel Hashomer, Israel, 52621
    • Pfizer Investigational Site
  • Zerifin, Israel, 70300
    • Pfizer Investigational Site
• Korea, Republic of
  • Seoul, Korea, Republic of, 138-736
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 110-744
    • Pfizer Investigational Site
  • Seoul, Korea, Republic of, 135-710
    • Pfizer Investigational Site
• Philippines
  • Makati City, Philippines, 1200
    • Pfizer Investigational Site
  • Manila, Philippines, 1008
    • Pfizer Investigational Site
  • Quezon City, Philippines, 1113
    • Pfizer Investigational Site
• Spain
  • Alicante, Spain, 03016
    • Pfizer Investigational Site
  • Barcelona, Spain, 08035
    • Pfizer Investigational Site
  • Valencia, Spain, 46014
    • Pfizer Investigational Site
• Taiwan
  • Taipei, Taiwan, 100
    • Pfizer Investigational Site
• Turkey
  • Ankara, Turkey, 06100
    • Pfizer Investigational Site
• United States
  • California
    • San Francisco, California, United States, 94143
      • Pfizer Investigational Site
  • Florida
    • Fort Myers, Florida, United States, 33912
      • Pfizer Investigational Site
    • Winter Haven, Florida, United States, 33880
      • Pfizer Investigational Site
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Pfizer Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • Pfizer Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site
  • Texas
    • Austin, Texas, United States, 78705
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm 1 ranibizumab; 0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12	Drug: 0.5 mg ranibizumab; Other Names: Lucentis
Experimental: Arm 2 ranibizumab and PF-04523655; 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; Other Names: Lucentis; Drug: 3 mg PF-04523655
Experimental: Arm 3 ranibizumab and PF-04523655; 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; Other Names: Lucentis; Drug: 1 mg PF-04523655
Experimental: Arm 4 ranibizumab and PF-04523655; 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; Other Names: Lucentis; Drug: 3 mg PF-04523655
Experimental: Arm 5 ranibizumab and PF-04523655; 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; Other Names: Lucentis; Drug: 1 mg PF-04523655

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	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
Change from Baseline in lesion size on FFA at Week 16	Week 16

Collaborators and Investigators

• Sponsor: Quark Pharmaceuticals
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): July 1, 2011

Study Registration Dates

• First Submitted: July 7, 2008
• First Submitted That Met QC Criteria: July 9, 2008
• First Posted (Estimate): July 11, 2008

Study Record Updates

• Last Update Posted (Estimate): October 12, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: AMD Age Related Macular Degeneration Choroidal Neovascularization Monet
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Neovascularization, Pathologic; Macular Degeneration; Choroidal Neovascularization; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Ranibizumab
• Other Study ID Numbers: B0451001