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). - Full Text View

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:

MedlinePlus related topics: Macular Degeneration

Drug Information available for: Ranibizumab

U.S. FDA Resources

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

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

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

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
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases

Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 16, 2013