Expired Study
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New York, New York 10119


Purpose:

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).


Criteria:

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.


NCT ID:

NCT00709527


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

New York, New York 10119
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 16, 2018

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