Diabetic Macular EdemaNCT05526729
Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection
An observational study of Diabetic Macular Edema, run by Novartis Pharmaceuticals at 76 sites in Japan.
Trial summary
This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance. Read more about this study
- Who is it for?
- Ages 0 to 99 years
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- Beovu
- How many people
- 222 participants
- Where
- 76 sitesJapan
- Study dates
- 2 Sep 2022to 29 Jun 2024
- 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 0 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients using Beovu for the first time for diabetic macular edema in Japan
Who may be able to join
- Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
- Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema
Who cannot join
- 1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu
Trial locations and contacts
76 sites in 1 country.
76 sites in 1 country
Japan76 sites
Novartis Investigative Site
Akita, 010-8543
Novartis Investigative Site
Arao, Kumamoto, 864-0041
Novartis Investigative Site
Asahikawa, Hokkaido, 078 8510
Novartis Investigative Site
Bunkyo Ku, Tokyo, 113 8655
Novartis Investigative Site
Chiyoda-ku, Tokyo, 101-8309
Novartis Investigative Site
Edogawa City, Tokyo, 134-0088
Novartis Investigative Site
Fukuoka, Fukuoka, 810-8563
Novartis Investigative Site
Fukuoka, Fukuoka, 812-8582
Novartis Investigative Site
Fukushima, Fukushima, 960 1295
Novartis Investigative Site
Hachiōji, Tokyo, 192-0081
Novartis Investigative Site
Hachiōji, Tokyo, 193-0944
Novartis Investigative Site
Hakodat, Hokkaido, 041-0806
Novartis Investigative Site
Hakodate, Hokkaido, 041-0851
Novartis Investigative Site
Hirakata, Osaka, 573-1191
Novartis Investigative Site
Inashiki, Ibaraki, 300 0395
Novartis Investigative Site
Iruma-gun, Saitama, 350-0495
Novartis Investigative Site
Ishioka, Ibaraki, 315-0037
Novartis Investigative Site
Jōetsu, Niigata, 943-0832
Novartis Investigative Site
Kagoshima, Kagoshima-ken, 890 8520
Novartis Investigative Site
Kashihara, Nara, 634 8522
Novartis Investigative Site
Kashiwa, Chiba, 277-0004
Novartis Investigative Site
Katsushika-ku, Tokyo, 125-8506
Novartis Investigative Site
Kisarazu, Chiba, 292-8535
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, 860-8556
Novartis Investigative Site
Kurashiki, Okayama-ken, 710-8602
Novartis Investigative Site
Kurume, Fukuoka, 830-0011
Novartis Investigative Site
Kyoto, Kyoto, 606-8397
Novartis Investigative Site
Kyoto, 6040837
Novartis Investigative Site
Maebashi, Gunma, 371 8511
Novartis Investigative Site
Matsumoto, Nagano, 390-8621
Novartis Investigative Site
Mito, Ibaraki, 310-0845
Novartis Investigative Site
Miyakonojō, Miyazaki, 885-0000
Novartis Investigative Site
Mizunami, Gifu, 509-6108
Novartis Investigative Site
Moriguchi, Osaka, 570-8507
Novartis Investigative Site
Musashino, Tokyo, 180-0023
Novartis Investigative Site
Nagakute, Aichi-ken, 480-1195
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8055
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8501
Novartis Investigative Site
Nagasaki, Nagasaki, 852-8511
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, 466-8650
Novartis Investigative Site
Nagoya, Aichi-ken, 467-8602
Novartis Investigative Site
Nankoku, Kochi, 783 8505
Novartis Investigative Site
Nishinomiya, Hyōgo, 662-0918
Novartis Investigative Site
Oda, Shimane, 694-0064
Novartis Investigative Site
Ohtsu, Shiga, 520-2192
Novartis Investigative Site
Ōita, Oita Prefecture, 870-0852
Novartis Investigative Site
Okayama, Okayama-ken, 701-0153
Novartis Investigative Site
Okayama, 700-0024
Novartis Investigative Site
Osaka, Osaka, 545-8586
Novartis Investigative Site
Osaka, 533-0024
Novartis Investigative Site
Osaka, 543-0027
Novartis Investigative Site
Ōsaka-sayama, Osaka, 589 8511
Novartis Investigative Site
Sakai, Osaka, 593-8304
Novartis Investigative Site
Sanjō, Niigata, 955-0852
Novartis Investigative Site
Sapporo, Hokkaido, 060 8648
Novartis Investigative Site
Sapporo, Hokkaido, 060-8604
Novartis Investigative Site
Shimotsuke, Tochigi, 329-0498
Novartis Investigative Site
Suita, Osaka, 565 0871
Novartis Investigative Site
Sumoto, Hyōgo, 656-0101
Novartis Investigative Site
tabashi City, Tokyo, 174-0053
Novartis Investigative Site
Taito-ku, Tokyo, 111-0051
Novartis Investigative Site
Takarazuka, Hyōgo, 665-0061
Novartis Investigative Site
Toyama, Toyama, 930-0194
Novartis Investigative Site
Ueda, Nagano, 386-0018
Novartis Investigative Site
Urayasu, Chiba, 279-0011
Novartis Investigative Site
Urayasu, Chiba, 279-0021
Novartis Investigative Site
Yokkaichi, Mie-ken, 510-8567
Novartis Investigative Site
Yokohama, Kanagawa, 245-0006
Novartis Investigative Site
Yoshida-gun, Fukui, 910-1193
Novartis Investigative Site
Yufu, Oita Prefecture, 879-5593
About this study
Official title: Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.
Read the detailed description
This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.
The observation period was 1 year (52 weeks) from the first Beovu administration in the primary treated eye.
In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied.
- Date of last Beovu dose + 90 days* in primary treated eye > Week 52: up to Week 52
- Date of last Beovu dose + 90 days* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days *90 days: to collect as much data as possible considering clinical effects
- Conditions
- Diabetic Macular Edema
- Being tested
- Beovu
- Keywords
- diabetic macular edema, DME, NIS, Japan, PMS, Beovu
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BeovuOther
Also called Brolucizumab
Prospective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study.
| Study group | Role | What they receive |
|---|---|---|
| Beovu | Patients prescribed with Beovu for diabetic macular edema Receives: Other: Beovu |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected.
Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion
Measured: Up to 52 weeks
Proportions of patients with adverse events in the eyes on therapy during the observation period
Proportions of patients with adverse events in the eyes on therapy during the observation period was collected
Measured: Up to 52 weeks
Proportion of patients with systemic adverse events during the observation period
Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected
Measured: Up to 52 weeks
Secondary outcomes (7)
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period was collected
Measured: Up to 52 weeks
Proportion of patients with systemic SAEs and adverse reactions during the observation period
Proportion of patients with systemic (non-ocular) SAEs and adverse reactions during the observation period was collected
Measured: Up to 52 weeks
Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period
Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period was collected.
Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion
Measured: Up to 52 weeks
Incidences of adverse events by risk factor of the safety specifications
Incidences of adverse events by risk factor of the safety specifications (primary treated eyes only) was collected.
Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion
Measured: Up to 52 weeks
Proportion of patients with VA worsening during the observation period
Proportion of patients with decimal VA worsening during the observation period was calculated.
VA was measured in best corrected visual acuity (BCVA). BCVA is the best possible vision that an eye can achieve with the use of glasses or contact lenses
Measured: Up to 52 weeks
Proportion of patients by administration status in the induction and maintenance phase during the observation period
Number of patients by administration status (yes/no) in the induction and maintenance phase during the observation period was collected
Measured: Up to 52 weeks
Proportion of patients by treated eye in the induction and maintenance phase during the observation period
Number of patients by treated eye (right eye/left eye) in the induction and maintenance phase during the observation period was collected
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start2 Sep 2022
- Primary completion29 Jun 2024
- Study completion29 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 222 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05526729
- Sponsor's protocol ID
- CRTH258B1401
- Status last verified
- Jun 2025
- First submitted
- 31 Aug 2022
- Last updated
- 13 Jun 2025
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Special Drug Use Observational Study With Beovu Kit for Intravitreal Injection (DME, CRTH258B1401)
- ClinicalTrials.gov ID
- NCT05526729
- Acronym / sponsor ID
- CRTH258B1401
- Conditions
- Diabetic Macular Edema
- Keywords
- diabetic macular edema, DME, NIS, Japan, PMS, Beovu
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 222 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Sep 2022 (actual)
- Primary completion
- 29 Jun 2024 (actual)
- Study completion
- 29 Jun 2024 (actual)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a primary data collection-based observational special drug-use surveillance to be conducted in accordance with the Good Post-marketing Study Practice (GPSP) ordinance.
Detailed description
This study aimed to evaluate the safety of Beovu kit for intravitreal injection in clinical use in diabetic macular edema (DME) patients.
The observation period was 1 year (52 weeks) from the first Beovu administration in the primary treated eye.
In patients discontinuing treatment with Beovu in the primary treated eye before Week 52, the following observation periods applied.
- Date of last Beovu dose + 90 days* in primary treated eye > Week 52: up to Week 52
- Date of last Beovu dose + 90 days* in primary treated eye ≤ Week 52: up to last dosing date in the primary treated eye + 90 days *90 days: to collect as much data as possible considering clinical effects
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Beovu | – | Other: BeovuPatients prescribed with Beovu for diabetic macular edema |
Who may qualify
- Ages
- 0 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients using Beovu for the first time for diabetic macular edema in Japan
Key inclusion criteria (2 listed)
- Patients must provide written consent to cooperate in this study before the start of treatment with Beovu
- Patients using Beovu for the first time for the following indication • Indication: diabetic macular edema
Key exclusion criteria (1 listed)
- 1. Patients with a history of treatment with a drug containing the same ingredient (brolucizumab) as Beovu
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BeovuAlso: BrolucizumabProspective observational study. There was no treatment allocation. Patients prescribed with Beovu for the first time for diabetic macular edema were eligible to enroll into this study. | Other | Beovu |
Primary outcome
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period
Time frame: Up to 52 weeks
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period was collected. Safety specifications: intraocular inflammation, endophthalmitis, intraocular pressure elevation, retinal detachment and retinal tear, retinal arterial embolic events, non-ocular arterial thromboembolic events, retinal vasculitis and retinal vascular occlusion
Proportions of patients with adverse events in the eyes on therapy during the observation period
Time frame: Up to 52 weeks
Proportions of patients with adverse events in the eyes on therapy during the observation period was collected
Proportion of patients with systemic adverse events during the observation period
Time frame: Up to 52 weeks
Proportion of patients with systemic (non-ocular) adverse events during the observation period was collected
7 secondary outcomes
Proportion of patients with serious adverse events (SAEs) and adverse reactions in the eyes on therapy during the observation period
Time frame: Up to 52 weeks
Proportion of patients with systemic SAEs and adverse reactions during the observation period
Time frame: Up to 52 weeks
Proportion of patients with SAEs, adverse reactions and serious adverse reactions corresponding to the safety specifications during the observation period
Time frame: Up to 52 weeks
Incidences of adverse events by risk factor of the safety specifications
Time frame: Up to 52 weeks
Proportion of patients with VA worsening during the observation period
Time frame: Up to 52 weeks
Proportion of patients by administration status in the induction and maintenance phase during the observation period
Time frame: Up to 52 weeks
Proportion of patients by treated eye in the induction and maintenance phase during the observation period
Time frame: Up to 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Results for CRTH258B1401 that is getting linked from the Novartis Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
76 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Novartis Pharmaceuticals at 76 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 2 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 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 76 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?
Proportion of patients with adverse events corresponding to each of the safety specifications during the observation period (time frame: Up to 52 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2025.