CompletedPhase 1

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

50 participantsStarted 2013-05

Plain-language 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).

Who can participate

Age range55 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye

Timeframe: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye

Timeframe: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment

Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment

Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

Trial details

NCT IDNCT01835015

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-11

Results submitted2016-01-12

View on ClinicalTrials.gov More Age-related Macular Degeneration trials

Who can participate

Age range55 Years – 90 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) by Visit - Study Eye

Timeframe: Baseline, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

Mean Intra-Ocular Pressure (IOP) by Visit - Study Eye

Timeframe: Baseline, Day 1, Day 2, Day 4, Day 15, Day 29, Day 57, Day 85

Number of Subjects With Change From Normal to Abnormal in Fundus Examination at Any Post-Therapy Visit as Compared to Baseline Assessment

Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85

Number of Subjects With a Change From Normal to Abnormal in Ocular Signs at Any Post-Therapy Visit as Compared to Baseline Assessment

Timeframe: Baseline, Day 2, Day 4, Day 8, Day 15, Day 29, Day 57, Day 85