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Trial record 3 of 19 for:    RTH258

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507388
Recruitment Status : Completed
First Posted : July 23, 2015
Results First Posted : September 29, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Brief 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).

Condition or disease Intervention/treatment Phase
Neovascular Age-Related Macular Degeneration Drug: Brolucizumab 3 mg/50 μL Drug: Brolucizumab 6 mg/50 μL Phase 2

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official 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
Actual Study Start Date : August 24, 2015
Actual Primary Completion Date : September 6, 2016
Actual Study Completion Date : September 6, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brolucizumab 3 mg
Brolucizumab 3 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
Drug: Brolucizumab 3 mg/50 μL
Administered as an intravitreal injection
Other Names:
  • RTH258
  • ESBA1008

Experimental: Brolucizumab 6 mg
Brolucizumab 6 mg/50 μL administered as an intravitreal injection 3 times at 4-week intervals with follow-up for 84 days from the initial injection
Drug: Brolucizumab 6 mg/50 μL
Administered as an intravitreal injection
Other Names:
  • RTH258
  • ESBA1008




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02507388


Sponsors and Collaborators
Alcon Research
Investigators
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Study Director: Alcon, A Novartis Division Alcon, A Novartis Division
Additional Information:
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Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02507388    
Other Study ID Numbers: RTH258-E003
First Posted: July 23, 2015    Key Record Dates
Results First Posted: September 29, 2017
Last Update Posted: July 2, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alcon Research:
AMD
nAMD
wetAMD
Age-Related Macular Degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Wet Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases