Skip to main content
OpenTrials
Completed

NCT Number: NCT02507388

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neovascular Age-related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

This study has 2 arms with a 1:1 randomization. Randomization will be stratified by Japanese ethnicity. Half of the subjects in each arm will be of Japanese ethnicity. The other half of the subjects in each arm will be non-Japanese. Subjects in both arms will have visits at Screening, Day 0 (Baseline), Day 1 (24 hours post first injection), Day 3, Day 14, Day 21, Day 28, Day 56, Day 57 (24 hours post the injection on Day 56) and Day 84.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brolucizumab 3 mg/50 μL

Drug

Administered as an intravitreal injection

Other names: RTH258, ESBA1008

Brolucizumab 6 mg/50 μL

Drug

Administered as an intravitreal injection

Other names: RTH258, ESBA1008

Primary outcomes

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

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

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.

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

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

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.

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

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

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.

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

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

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.

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

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

    Serum concentrations at each collection time point were quantitated, where possible, using a validated immunoassay method. These data were analyzed using a noncompartmental pharmacokinetic (PK) method.

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

    Time frame: Day 1

    Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.

  7. Concentration of RTH258 Obtained 24 Hours Post Day 56 Injection [C24hr (ng/mL)]

    Time frame: Day 57

    Serum concentration at the specified collection time point was quantitated, where possible, using a validated immunoassay method. The data were analyzed using a noncompartmental pharmacokinetic (PK) method.

Secondary outcomes

  1. Percentage of Subjects With Positive Anti-drug Antibody (ADA) Status (Test)

    Time frame: Day 0 (predose), Day 28, Day 84

    A positive ADA status is defined as induced ADA status with ADA negative at predose and with a post-dose titer value increase of 2 or more dilutions at any time point or boosted ADA status with ADA positive at predose and a post-dose titer value increase by more than 3-fold (1 dilution) at any time point.

Sponsors and collaborators

Lead sponsor

Alcon Research

Industry

Registry information

Official study title

A Randomized, Double Masked, Three Dose Safety and Pharmacokinetic Study of RTH258 Following Intravitreal (IVT) Injection in Subjects With Neovascular Age-Related Macular Degeneration

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2015
Registry last updated
Jul 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.