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

Age-related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01835015
• Other study ID #: C-12-074
• Status: Completed
• Phase: Phase 1
• First received: April 16, 2013
• Last updated: November 11, 2014
• Start date: May 2013
• Est. completion date: November 2014

Study information

• Verified date: November 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects will be divided into 4 cohorts, with the subjects in each cohort being administered a single IVT dose of CLG561. If necessary, 2 additional cohorts may be enrolled to repeat a dose cohort, test an intermediate dose, or test a higher/lower dose. All subjects will receive active 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• CLG561
Administered by intravitreal injection, Day 1

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Best Corrected Visual Acuity (BCVA)	BCVA will be measured using Early Treatment Diabetic Retinopathy Study visual acuity charts	Baseline, up to Day 85	Yes
Primary	Intra-Ocular Pressure (IOP)	IOP will be measured by Goldmann applanation tonometry or tonopen, at the discretion of the Investigator.	Up to Day 85	Yes
Primary	Change from Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment	A dilated fundus examination will be performed to evaluate the health of the vitreous, retina, macula, choroid, and optic nerve	Baseline, up to Day 85	Yes
Primary	Change from Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment	A slit-lamp biomicroscopy examination will be performed to evaluate the anterior segment of the eye	Baseline, up to Day 85	Yes
Secondary	Area under the serum concentration-time curve from time zero to infinity [AUC(0-8)]	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-tlast)]	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Area under the serum concentration-time curve from time zero to time "t" where t is a defined time point after administration [AUC(0-t)]	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Time to reach the maximum serum concentration after drug administration (Tmax)	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Dose normalized observed maximum serum concentration following drug administration (Cmax/D)	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Dose-normalized area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC/D)	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Terminal elimination half-life (T½)	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	The apparent volume of distribution during the terminal elimination phase following extravascular administration (Vz/F)	Contingent upon observed serum concentration levels	Up to Day 85	No
Secondary	Apparent systemic (or total body) clearance from serum following extravascular administration (CL/F)	Contingent upon observed serum concentration levels	Up to Day 85	No