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).

Quark Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Age Related Macular Degeneration

Treatments: Drug: 1 mg PF-04523655; Drug: 0.5 mg ranibizumab; Drug: 3 mg PF-04523655

Study type: Interventional

Funder types: Industry

Identifiers

NCT00713518

B0451001

Details and patient eligibility

About

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

Enrollment: 152 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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152 participants in 5 patient groups

Arm 1 ranibizumab

Active Comparator group

Description:

0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12

Treatment:

Drug: 0.5 mg ranibizumab

Arm 2 ranibizumab and PF-04523655

Experimental group

Description:

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

Treatment:

Drug: 0.5 mg ranibizumab

Drug: 3 mg PF-04523655

Arm 3 ranibizumab and PF-04523655

Experimental group

Description:

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

Treatment:

Drug: 0.5 mg ranibizumab

Drug: 1 mg PF-04523655

Arm 4 ranibizumab and PF-04523655

Experimental group

Description:

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

Treatment:

Drug: 0.5 mg ranibizumab

Drug: 3 mg PF-04523655

Arm 5 ranibizumab and PF-04523655

Experimental group

Description:

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

Treatment:

Drug: 0.5 mg ranibizumab

Drug: 1 mg PF-04523655