CompletedPhase 2

Safety and Pharmacokinetics of RTH258 in Subjects With Age-Related Macular Degeneration

51 participantsStarted 2015-08-24

Plain-language summary

The purpose of this study is to assess the systemic pharmacokinetics (PK) and safety of 2 different doses of brolucizumab (3 milligrams (mg)/50 microliters (μL) and 6 mg/50 μL) when administered at 4-week intervals for a total of 3 intravitreal injections in subjects with neovascular age-related macular degeneration (AMD).

Who can participate

Age range

50 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: * Provide written informed consent; * Active choroidal neovascularization (CNV) lesions secondary to AMD that affect the central subfield in the study eye; * Best Corrected Visual Acuity (BCVA) \> 23 letters in the study eye at Baseline; * 50 years of age or older at the time of Screening. Exclusion Criteria: * Any active ocular infection or inflammation; * Treatment with aflibercept (EYLEA®), bevacizumab (AVASTIN®), ranibizumab (LUCENTIS®), brolucizumab, or an investigational drug for neovascular AMD prior to enrollment in the study, as specified in protocol; * Ocular surgery in the study eye, as specified in protocol; * Uncontrolled glaucoma in the study eye, as specified in protocol; * Use of steroids in the study eye, as specified in protocol; * Medical conditions that may prevent study completion; * Pregnant or nursing (lactating) women; * Women of child-bearing potential unless using contraception; * Uncontrolled blood pressure, as specified in protocol; * Other protocol-specified 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

Maximum Analyte Serum Concentration [Cmax (ng/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Elimination Half-life in Serum [t1/2 (h)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]

Timeframe: Day 1

Trial details

NCT IDNCT02507388

SponsorAlcon Research

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-06

Results submitted2017-09-05

View on ClinicalTrials.gov More Neovascular Age-Related Macular Degeneration trials

Plain-language summary

Who can participate

Age range

50 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

Maximum Analyte Serum Concentration [Cmax (ng/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Time to Reach Maximum Analyte Serum Concentration [Tmax (h)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration [AUC0-tlast (ng*h/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Area Under the Concentration-time Curve From 0 to Infinity [AUC0-inf (ng*h/mL)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Elimination Half-life in Serum [t1/2 (h)]

Timeframe: Day 0 (predose), 6 hr, 24 hr, 72 hr, 168 hr, 336 hr, 504 hr, 672 hr

Concentration of RTH258 Obtained 24 Hours Post Day 0 Injection [C24hr (ng/mL)]

Timeframe: Day 1