Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:55 - 90
Updated:5/5/2014
Start Date:May 2013
End Date:May 2014
Contact:Alcon Call Center
Email:alcon.medinfo@alcon.com
Phone:1-888-451-3937

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A Multi-Center, Open-Label, Single Ascending Dose Study To Assess the Safety, Tolerability, and Serum Pharmacokinetics of Intravitreal CLG561 in Subjects With Advanced Age-Related Macular Degeneration

The purpose of this study is to evaluate the safety, tolerability, and serum
pharmacokinetics of CLG561 in subjects with advanced age-related macular degeneration.

Subjects will be divided into 4 cohorts, with the subjects in each cohort being administered
a single IVT dose of CLG561. Progress from one cohort to the next will be time-lagged to
allow for safety review. Dosing will also be time-lagged within each cohort. Only one eye
(designated as the study eye) will be dosed per subject. Post-dose safety assessments and
ocular examination will commence immediately after the IVT injection and continue throughout
the outpatient visits at pre-determined timepoints. Collection of post-injection blood
samples will also begin after the IVT injection at pre-determined timepoints.

Inclusion Criteria:

- Diagnosis of age-related macular degeneration in study eye, as specified in protocol.

- Poor visual acuity in study eye, as specified in protocol.

- Willing to receive meningitis and pneumonia vaccinations at least 2 weeks prior to
study treatment.

- Females must be post-menopausal and/or surgically sterile.

- Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

- Treatments to the study eye within 28 days prior to study treatment, as specified in
protocol.

- Any disease or medication expected to cause systemic or ocular immunosuppression.

- Participation in another interventional clinical study or use of any experimental
treatment for AMD within 12 weeks prior to study treatment.

- Other protocol-defined exclusion criteria may apply.
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