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 range

55 Years – 90 Years

Sex

ALL

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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 range

55 Years – 90 Years

Sex

ALL

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