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PF-04523655 vs Ranibizumab in wet AMD (MONET)
NCT00713518Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2009
- Primary completion
- Nov 2010
- Countries
- 11
- Sponsor
- Quark Pharmaceuticals
- Modality
- Conjugated siRNA, Chemically Modified siRNA
- Drugs
- PF-04523655
- Conditions
- exudative macular degeneration
01
Overview
Phase 2, randomised, open-label trial of PF-04523655 in exudative macular degeneration (5 arms), sponsored by Quark Pharmaceuticals. Primary endpoint: Mean change in the best corrected visual acuity score at 16 weeks. Started Nov 2009; status: completed.
02
Design
5 arms- Study design
- RandomizedOpen-label
Arm 1 ranibizumab
0.5 mg ranibizumab intravitreal injection given every 4 weeks from baseline to Week 12
Arm 2 ranibizumab and PF-04523655
0.5 mg ranibizumab at baseline followed by 3 mg PF-04523655 every 2 weeks from Week 4 to Week 12
Arm 3 ranibizumab and PF-04523655
0.5 mg ranibizumab at baseline followed by 1 mg PF-04523655 every 4 weeks to Week 12
Arm 4 ranibizumab and PF-04523655
0.5 mg ranibizumab at baseline followed by 3 mg PF-04523655 every 4 weeks from Week 4 to Week 12
Arm 5 ranibizumab and PF-04523655
0.5 mg ranibizumab at baseline followed by 1 mg PF-04523655 (30 minutes later) given in combination every 4 weeks from baseline to Week 12
03
Who it enrols
Patients 50+ with active subfoveal CNV secondary to AMD, lesion size <= 12 disc areas, and BCVA 20/40-20/320. Excludes prior PDT, radiation, submacular surgery, or recent anti-VEGF/steroid treatment.
04
Endpoints
Primary
Mean change in the best corrected visual acuity score
Secondary
Percent of subjects gaining >/=15 letters in BCVA
Mean change from Baseline over time in BCVA
Incidence and severity of ocular adverse events
Change in retinal central subfield thickness and retinal lesion thickness
Incidence and severity of systemic adverse events
Change from Baseline in lesion size on FFA
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