Status:
COMPLETED
Pharmacokinetics of CLG561 in Patients With Advanced Age-Related Macular Degeneration
Lead Sponsor:
Alcon Research
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
55-90 years
Phase:
PHASE1
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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01835015
Start Date
May 1 2013
End Date
November 1 2014
Last Update
March 25 2016
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