Neovascular GlaucomaNCT04519619
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
An observational study of Neovascular Glaucoma, run by Bayer at 1 site in Japan.
Trial summary
This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neovascular Glaucoma
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- Type of treatment
- Injection or infusion
- How many people
- 480 participants
- Where
- 1 siteJapan
- Study dates
- 27 Nov 2020to 30 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator. Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.
Who may be able to join
- Diagnosis of NVG
- Patients who have received IVT-AFL treatment according to Japanese labeling.
Who cannot join
- Patients who are contraindicated based on approved label
- Diagnosis of other indication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
This is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.
The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).
- Conditions
- Neovascular Glaucoma
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- Medical subject headings
- Glaucoma, Neovascular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
Administration by intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of participants with adverse events (AEs)
Measured: Up to 6 months
Secondary outcomes (3)
Intraocular Pressure (IOP) value after study drug administration
In case of transient and/or persistent IOP elevation
Measured: Up to 6 months
Mean changes in Visual Acuity
Measured: Up to 6 months
Proportion of participants with improvement of anterior neovascularization
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start27 Nov 2020
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular GlaucomaStudies of the same condition, open and under way.
- More trials run by BayerThe 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
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519619
- Sponsor's protocol ID
- 21220
- Status last verified
- Jun 2026
- First submitted
- 18 Aug 2020
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Use Investigation for Eylea for Neovascular Glaucoma (NVG)
- ClinicalTrials.gov ID
- NCT04519619
- Acronym / sponsor ID
- 21220
- Conditions
- Neovascular Glaucoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 19 Aug 2020 (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 is a prospective, observational, multi-center and post-authorization safety study that includes patients with a diagnosis of Neovascular Glaucoma. The investigator will have made the decision to use Eylea for treatment.
The objective of this study is to assess safety and effectiveness of Eylea using in real clinical practice. Patients will be followed for a time period of 6 months from start of Eylea treatment or until it is no longer possible (e.g. lost to follow-up). In total, 480 patients will be recruited. For each patient, data are collected as defined in the electronic case report form (eCRF) at the initial visit, follow-up visit and final visit, either by routine clinical visits (as per investigators routine practice).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321) | – | Drug: Aflibercept (Eylea, BAY86-5321)Decision of Eylea treatment is made by attending investigators according to the Japanese Package Insert |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with a diagnosis of NVG will be enrolled after the decision for treatment with Aflibercept (AFL) has been made by the investigator. Participants who have been prescribed AFL for a medically appropriate use will be eligible to be enrolled. Indications and contraindications according to the local market authorization should be carefully considered.
Key inclusion criteria (2 listed)
- Diagnosis of NVG
- Patients who have received IVT-AFL treatment according to Japanese labeling.
Key exclusion criteria (2 listed)
- Patients who are contraindicated based on approved label
- Diagnosis of other indication
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 |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321)Administration by intravitreal injection | Drug | Aflibercept (Eylea, BAY86-5321) |
Primary outcome
The number of participants with adverse events (AEs)
Time frame: Up to 6 months
3 secondary outcomes
Intraocular Pressure (IOP) value after study drug administration
Time frame: Up to 6 months
Mean changes in Visual Acuity
Time frame: Up to 6 months
Proportion of participants with improvement of anterior neovascularization
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No. Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
Related trials for Neovascular Glaucoma
RecruitingObservational study
Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma
Neovascular Glaucoma, Type 2 Diabetes
Active, not recruiting
Minimally Invasive Suprachoroidal Drainage for the Treatment of Neovascular Glaucoma
Neovascular Glaucoma
Recruiting
Intracameral Versus Intravitreal Bevacizumab Injection in NVG: RCT
Glaucoma, Neovascular, Vascular Endothelial Growth Factor Overexpression
Active, not recruitingPhase 1
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
Neovascular Glaucoma, Neovascularization
Enrolling by invitationObservational study
INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register
Glaucoma Open-Angle, Glaucoma Eye
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neovascular Glaucoma, run by Bayer at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of participants with adverse events (AEs) (time frame: Up to 6 months). 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 30 Jun 2026.