Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00713518
Recruitment Status : Completed
First Posted : July 11, 2008
Last Update Posted : October 12, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Drug: 0.5 mg ranibizumab Drug: 3 mg PF-04523655 Drug: 1 mg PF-04523655 Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 152 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Lucentis

Drug: 1 mg PF-04523655



Primary Outcome Measures :
  1. Mean change in the best corrected visual acuity score measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol by Week 16 [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: Week 16 ]
  2. Mean change from Baseline over time (16 weeks) in the best corrected visual acuity score, as measured using the ETDRS protocol [ Time Frame: Week 16 ]
  3. Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported [ Time Frame: Week 48 ]
  4. Change from Baseline to Weeks 4,8, 12, and 16 in retinal central subfield thickness and retinal lesion thickness assessed by OCT [ Time Frame: Week 16 ]
  5. Incidence and severity of systemic adverse events identified by physical examination, changes in vital signs, clinical laboratory abnormalities and or spontaneously reported [ Time Frame: Week 48 ]
  6. Change from Baseline in lesion size on FFA at Week 16 [ Time Frame: Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00713518


Locations
Layout table for location information
United States, California
Pfizer Investigational Site
San Francisco, California, United States, 94143
United States, Florida
Pfizer Investigational Site
Fort Myers, Florida, United States, 33912
Pfizer Investigational Site
Winter Haven, Florida, United States, 33880
United States, Georgia
Pfizer Investigational Site
Augusta, Georgia, United States, 30909
United States, Indiana
Pfizer Investigational Site
Indianapolis, Indiana, United States, 46290
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
United States, Texas
Pfizer Investigational Site
Austin, Texas, United States, 78705
Austria
Pfizer Investigational Site
Linz, Austria, A-4021
Pfizer Investigational Site
Wien, Austria, A-1030
Denmark
Pfizer Investigational Site
Glostrup, Denmark, 2600
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong, 0
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 004
Pfizer Investigational Site
Navrangpura, Ahmedabad, Gujarat, India, 380009
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641014
Pfizer Investigational Site
New Delhi, India, 110029
Israel
Pfizer Investigational Site
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
Korea, Republic of
Pfizer Investigational Site
Seoul, Korea, Republic of, 110-744
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Philippines
Pfizer Investigational Site
Makati City, Philippines, 1200
Pfizer Investigational Site
Manila, Philippines, 1008
Pfizer Investigational Site
Quezon City, Philippines, 1113
Spain
Pfizer Investigational Site
Alicante, Spain, 03016
Pfizer Investigational Site
Barcelona, Spain, 08035
Pfizer Investigational Site
Valencia, Spain, 46014
Taiwan
Pfizer Investigational Site
Taipei, Taiwan, 100
Turkey
Pfizer Investigational Site
Ankara, Turkey, 06100
Sponsors and Collaborators
Quark Pharmaceuticals
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00713518    
Other Study ID Numbers: B0451001
First Posted: July 11, 2008    Key Record Dates
Last Update Posted: October 12, 2012
Last Verified: October 2012
Keywords provided by Quark Pharmaceuticals:
AMD Age Related Macular Degeneration Choroidal Neovascularization Monet
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents