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

NCT ID: NCT01835015

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-11-30

Brief Summary

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).

Detailed 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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

CLG561, Concentration Level A

Single 50 μL intravitreal injection of CLG561, Dose Level A

Group Type: EXPERIMENTAL

CLG561

Intervention Type: DRUG

Administered by intravitreal injection, Day 1

CLG561, Concentration Level B

Single 50 μL intravitreal injection of CLG561, Dose Level B

Group Type: EXPERIMENTAL

CLG561

Intervention Type: DRUG

Administered by intravitreal injection, Day 1

CLG561, Concentration Level C

Single 50 μL intravitreal injection of CLG561, Dose Level C

Group Type: EXPERIMENTAL

CLG561

Intervention Type: DRUG

Administered by intravitreal injection, Day 1

CLG561, Concentration Level D

Single 50 μL intravitreal injection of CLG561, Dose Level D

Group Type: EXPERIMENTAL

CLG561

Intervention Type: DRUG

Administered by intravitreal injection, Day 1

CLG561, Concentration Level E

Single 100 μL intravitreal injection of CLG561, Dose Level E

Group Type: EXPERIMENTAL

CLG561

Intervention Type: DRUG

Administered by intravitreal injection, Day 1

Interventions

CLG561

Administered by intravitreal injection, Day 1

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Head of Clinical Sciences, CA CSI NS/Opth

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-12-074

Identifier Type: -

Identifier Source: org_study_id