Age-related Macular Degeneration
Conditions
Brief summary
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).
Interventions
DRUGE10030
Intravitreal injection
Sponsors
Ophthotech Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
Subfoveal choroidal neovascularization (CNV) due to AMD
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ophthalmic DLTs | immediate |
Secondary
| Measure | Time frame |
|---|---|
| adverse events | immendiate |
Countries
United States
Outcome results
None listed