Neovascular Age-Related Macular Degeneration
Conditions
Keywords
AMD
Brief summary
The objectives of this study are to evaluate the safety, tolerability, and pharmacokinetic profile of multiple doses of ARC1905 intravitreous injection when administered in combination with multiple doses of Lucentis® 0.5 mg/eye, or with one induction dose of Lucentis 0.5 mg/eye in subjects with subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD).
Interventions
intravitreal injection
Sponsors
Ophthotech Corporation
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subfoveal choroidal neovascularization (CNV) due to AMD (i.e., predominately classic, minimally classic or occult no classic) as documented by fluorescein angiogram.
Exclusion criteria
* Previous or concomitant therapy with intravitreous corticosteroids. * Any of the following underlying diseases including: * Diabetic retinopathy * History or evidence of severe cardiac disease (e.g., NYHA Functional Class III or IV), history or clinical evidence of unstable angina, acute coronary syndrome, myocardial infarction or revascularization within last 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. Patients with results outside these ranges may be enrolled in consultation with Ophthotech. * 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. * Women who are pregnant or nursing. * Known serious allergies to the fluorescein dye used in angiography, to the components of the ranibizumab formulation, or to the components of the ARC1905 formulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence of any dose-limiting toxicity (DLT), safety endpoints include adverse events, vital signs, ophthalmic variables and outcomes | 2 years |
Countries
United States
Outcome results
None listed