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

Alcon

Status and phase: Completed; Phase 1

Conditions: Age-related Macular Degeneration

Treatments: Drug: CLG561

Study type: Interventional

Funder types: Industry

Identifiers

NCT01835015

C-12-074

Details and patient eligibility

About

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

Full description

Subjects were divided into 5 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561 in 1 of 5 concentration levels A-E, where A=lowest and E=highest. All subjects received active CLG561. Progress from one cohort to the next was time-lagged to allow for safety review. Dosing was also time-lagged within each cohort. Only one eye (designated as the study eye) was dosed per subject. Post-dose safety assessments and ocular examination occurred immediately after the IVT injection and continued throughout the outpatient visits at pre-determined timepoints. Collection of post-injection blood samples began after the IVT injection at pre-determined timepoints. Subjects were followed for up to 84 days.

Enrollment: 50 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 5 patient groups

CLG561, Concentration Level A

Experimental group

Description:

Single 50 μL intravitreal injection of CLG561, Dose Level A

Treatment:

Drug: CLG561

CLG561, Concentration Level B

Experimental group

Description:

Single 50 μL intravitreal injection of CLG561, Dose Level B

Treatment:

Drug: CLG561

CLG561, Concentration Level C

Experimental group

Description:

Single 50 μL intravitreal injection of CLG561, Dose Level C

Treatment:

Drug: CLG561

CLG561, Concentration Level D

Experimental group

Description:

Single 50 μL intravitreal injection of CLG561, Dose Level D

Treatment:

Drug: CLG561

CLG561, Concentration Level E

Experimental group

Description:

Single 100 μL intravitreal injection of CLG561, Dose Level E

Treatment:

Drug: CLG561