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Neovascular Age-related Macular DegenerationNCT04632056

A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab in Patients With nAMD

An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 67 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients. Read more about this study

Who is it for?
Ages Up to 99 years
What is being tested?
Beovu
Type of treatment
Injection or infusion
How many people
329 participants
Where
67 sitesJapan
Study dates
16 Nov 2020to 10 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 99 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: The population was patients using Beovu kit for intravitreal injection for nAMD with subfoveal CNV

Who may be able to join

  • Patients must provide written consent to cooperate in this study before treatment with Beovu kit for intravitreal injection
  • Patients using Beovu kit for intravitreal injection for the first time for the following indication:
  • Indication: age-related macular degeneration with subfoveal choroidal neovascularization

Who cannot join

  • 1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab; investigational drug or post-marketing clinical study drug) as Beovu kit for intravitreal injection

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

Japan67 sites

  • Novartis Investigative Site

    Akita, 010-8543

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113 8655

  • Novartis Investigative Site

    Bunkyo Ku, Tokyo, 113-8431

  • Novartis Investigative Site

    Chiyoda-ku, Tokyo, 101-8309

  • Novartis Investigative Site

    Fukuoka, 814-0011

  • Novartis Investigative Site

    Fukuoka, 814-0013

  • Novartis Investigative Site

    Fukuoka, 814-0193

  • Novartis Investigative Site

    Fukuoka, 819-8585

  • Novartis Investigative Site

    Hachiōji, Tokyo, 193-0944

  • Novartis Investigative Site

    Hakodat, Hokkaido, 041-0806

  • Novartis Investigative Site

    Hakodate, Hokkaido, 041-0851

  • Novartis Investigative Site

    Hamamatsu, Shizuoka, 430-8558

  • Novartis Investigative Site

    Hirakata, Osaka, 573-1191

  • Novartis Investigative Site

    Hiroshima, 731-5133

  • Novartis Investigative Site

    Iizuka, Fukuoka, 820-0043

  • Novartis Investigative Site

    Iruma-gun, Saitama, 350-0495

  • Novartis Investigative Site

    Ishioka, Ibaraki, 315-0037

  • Novartis Investigative Site

    Izunokuni, Shizuoka, 410-2295

  • Novartis Investigative Site

    Kakogawa-shi, Hyōgo, 675-8611

  • Novartis Investigative Site

    Kanazawa, Ishikawa-ken, 921-8161

  • Novartis Investigative Site

    Kashihara, Nara, 634 8522

  • Novartis Investigative Site

    Kesennuma, Miyagi, 988-0052

  • Novartis Investigative Site

    Kita-gun, Kagawa-ken, 761-0793

  • Novartis Investigative Site

    Kobe, Hyōgo, 650-0047

  • Novartis Investigative Site

    Kobe, Hyōgo, 652-0863

  • Novartis Investigative Site

    Kumamoto, Kumamoto, 860-8556

  • Novartis Investigative Site

    Kure, Hiroshima, 737-0029

  • Novartis Investigative Site

    Kurume, Fukuoka, 830-0011

  • Novartis Investigative Site

    Kyoto, 604-0837

  • Novartis Investigative Site

    Matsumoto, Nagano, 390-8621

  • Novartis Investigative Site

    Mito, Ibaraki, 310-0845

  • Novartis Investigative Site

    Miyakonojō, Miyazaki, 885-0000

  • Novartis Investigative Site

    Moriguchi, Osaka, 570-8507

  • Novartis Investigative Site

    Musashino, Tokyo, 180-0006

  • Novartis Investigative Site

    Nagasaki, Nagasaki, 852-8511

  • Novartis Investigative Site

    Nagasaki, 850-0918

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 456-0032

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 457 8510

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 460-0008

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 462-0825

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 466 8560

  • Novartis Investigative Site

    Nakagami, Okinawa, 903 0215

  • Novartis Investigative Site

    Nishinomiya, Hyōgo, 663 8501

  • Novartis Investigative Site

    Oda, Shimane, 694-0064

  • Novartis Investigative Site

    Ohtsu-city, Shiga, 520-0046

  • Novartis Investigative Site

    Ohtsu-city, Shiga, 520-2192

  • Novartis Investigative Site

    Okayama, Okayama-ken, 700-8558

  • Novartis Investigative Site

    Okayama, 701-0153

  • Novartis Investigative Site

    Osaka, Osaka, 543-8555

  • Novartis Investigative Site

    Osaka, 545-8586

  • Novartis Investigative Site

    Ōsaka-sayama, Osaka, 589 8511

  • Novartis Investigative Site

    Saitama-shi, Saitama, 336-0963

  • Novartis Investigative Site

    Sakai, Osaka, 593-8304

  • Novartis Investigative Site

    Sapporo, Hokkaido, 060-0010

  • Novartis Investigative Site

    Sendai, Miyagi, 980 8574

  • Novartis Investigative Site

    Sendai, Miyagi, 980-0824

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 329-0498

  • Novartis Investigative Site

    Shinjuku Ku, Tokyo, 162 8666

  • Novartis Investigative Site

    Shinjuku-ku, Tokyo, 160 8582

  • Novartis Investigative Site

    Shizuoka, Shizuoka, 422-8076

  • Novartis Investigative Site

    Suita, Osaka, 565 0871

  • Novartis Investigative Site

    Toyohashi, Aichi-ken, 441-8106

  • Novartis Investigative Site

    Urayasu, Chiba, 279-0021

  • Novartis Investigative Site

    Urazoe, Okinawa, 901-2133

  • Novartis Investigative Site

    Yokkaichi, Mie-ken, 510-8567

  • Novartis Investigative Site

    Yokohama, Kanagawa, 232 0024

  • Novartis Investigative Site

    Yokosuka, Kanagawa, 238-8558

Other trials in Japan

About this study

Official title: A 52-weeks Observational Study to Evaluate the Safety of Brolucizumab (6mg) in Patients With Neovascular Age-related Macular Degeneration (nAMD)

This study was a prospective, uncontrolled, central registration system, multicenter, domestic observational study (special drug-use surveillance) to evaluate the safety of 52-week clinical treatment with Beovu kit for intravitreal injection in nAMD patients.

Read the detailed description

The observational period was 1 year (52 weeks) from the first brolucizumab administration in the primary treated eye.

However, if brolucizumab was discontinued in the primary treated eye and if the treatment was discontinued less than 52 weeks observation period, the observation period was to be up to 90 days after the last dose of this drug. This was set in order to collect data as much as possible based on the clinical effect of the drug. If 30 days after the last dose of this drug in a discontinued patient exceeds 52 weeks of the observation period, the patient was to be monitored for adverse events until 30 days after the last dose of this drug.

Being tested
Beovu
Keywords
Japan, brolucizumab, neovascular age-related macular degeneration, (nAMD), non-interventional study, post-marketing surveillance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BeovuDrug

    Also called Brolucizumab

    There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study were enrolled.

Study groups in NCT04632056
Study groupRoleWhat they receive
BeovuBrolucizumab (Genetical Recombination) 6 mg (0.05 mL) was administered by intravitreal injection every 4 weeks for the first three doses(loading phase). In the following maintenance phase, Brolucizumab was basically administered every 12 weeks. The interval between treatments was adjusted as appropriate according to the symptoms. The interval between two doses was not to be shorter than 8 weeks
Receives: Drug: Beovu

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with adverse events in the eyes on therapy

    Number of patients with adverse events (AEs) in the eyes on therapy were reported

    Measured: 52 weeks

  2. Number of patients with adverse events in other parts of the body (non-ocular)

    Number of patients with adverse events (AEs) in other parts of the body (non-ocular) were reported

    Measured: 52 weeks

Secondary outcomes (6)

  1. Number of patients with serious adverse events (SAEs) and adverse reactions (ADRs) in the eyes on therapy

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.

    Measured: 52 weeks

  2. Number of patients with SAEs and ADRs in other parts of the body (non-ocular)

    A SAE is defined as an AE whose description suggests that it is serious or whose outcome is fatal.

    An adverse reaction is defined as an adverse event that is suspected by the investigator to be causally related to Beovu or administration procedures, or whose causality is not recorded.

    Measured: 52 weeks

  3. Number of patients with adverse events, SAEs, ADRs and serious ADRs corresponding to the safety specifications

    The following events were chosen as the safety specifications for this study that should be investigated:

    • Intraocular inflammation
    • Endophthalmitis
    • Increased intraocular pressure
    • Retinal pigment epithelial tear
    • Retinal detachment and retinal tear
    • Retinal artery embolic events
    • Non-ocular arterial thromboembolic events
    • Retinal vasculitis and retinal vascular occlusion

    Measured: 52 weeks

  4. Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only)

    Incidence of adverse events by risk factor of the safety specifications (primary treated eyes only) were reported

    Measured: 52 weeks

  5. Proportion of patients with visual acuity (VA) worsening

    Visual acuity commonly refers to the clarity of vision

    Measured: 52 weeks

  6. Data on Beovu administration in the induction phase and maintenance phase

    For data on Beovu administration (dosing duration, dosing frequency) in the primary treated eye and the secondary primary eyes in the safety analysis set, summary statistics were calculated respectively. The same calculation applied to data on administration respectively for the induction period and the maintenance period.

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Nov 2020
  2. Study start16 Nov 2020
  3. Primary completion10 Nov 2022
  4. Study completion10 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
329 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04632056
Sponsor's protocol ID
CRTH258A1401
Status last verified
Nov 2023
First submitted
12 Nov 2020
Last updated
14 Nov 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Neovascular Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 67 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with adverse events in the eyes on therapy (time frame: 52 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04632056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2023.

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