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).

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00713518
First received: July 7, 2008
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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 Intervention Phase
Age Related Macular Degeneration
Drug: 0.5 mg ranibizumab
Drug: 3 mg PF-04523655
Drug: 1 mg PF-04523655
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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).

Resource links provided by NLM:


Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence and severity of ocular adverse events identified by ophthalmic examination and or spontaneously reported [ Time Frame: Week 48 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Change from Baseline in lesion size on FFA at Week 16 [ Time Frame: Week 16 ] [ Designated as safety issue: Yes ]

Enrollment: 152
Study Start Date: November 2009
Study Completion Date: July 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00713518

  Show 31 Study Locations
Sponsors and Collaborators
Quark Pharmaceuticals
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Quark Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00713518     History of Changes
Other Study ID Numbers: B0451001
Study First Received: July 7, 2008
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Quark Pharmaceuticals:
AMD Age Related Macular Degeneration Choroidal Neovascularization Monet

Additional relevant MeSH terms:
Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014