The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic
profile of E10030 intravitreous injection when administered as monotherapy or in
combination with Lucentis® 0.5 mg/eye in subjects with subfoveal choroidal
neovascularization secondary to age-related macular degeneration (AMD).
Subfoveal choroidal neovascularization (CNV) due to AMD
- Any of the following underlying diseases including:
- Diabetic retinopathy.
- History or evidence of severe cardiac disease (e.g., NYHA Functional Class III
or IV - see Appendix 19.6), history or clinical evidence of unstable angina,
acute coronary syndrome, myocardial infarction or revascularization with 6
months, ventricular tachyarrythmias requiring ongoing treatment.
- History or evidence of clinically significant peripheral vascular disease, such
as intermittent claudication or prior amputation.
- Clinically significant impaired renal (serum creatinine >2.5 mg/dl or s/p renal
transplant or receiving dialysis) or hepatic function.
- Stroke (within 12 months of trial entry).
- Any major surgical procedure within one month of trial entry. Previous
therapeutic radiation in the region of the study eye. Any treatment with an
investigational agent in the past 60 days for any condition.
Known serious allergies to the fluorescein dye used in angiography, to the components of
the ranibizumab formulation, or to the components of the E10030 formulation.