Glaucoma, NeovascularPhase 3VENERANCT03639675
Study to Learn How the Drug Aflibercept Works in in Japanese Patients With Increased Eye Pressure That is Caused by New Blood Vessels Growing in the Eye (Neovascular Glaucoma or NVG). Safety of the Drug and Patients' Tolerability of the Drug Injection is Also Studied
A Phase 3 study testing Aflibercept (EYLEA, BAY86-5321) and Topical IOP-lowering drugs in people with Glaucoma, Neovascular, run by Bayer at 7 sites in Japan.
Trial summary
The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma, Neovascular
- What is being tested?
- Aflibercept (EYLEA, BAY86-5321) and Topical IOP-lowering drugs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 7 sitesJapan
- Study dates
- 3 Oct 2018to 14 Mar 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese men and women aged 20 years or older
- Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle)
- Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization
Who cannot join
- Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG
- Patients with a known or suspected ocular or peri-ocular infection
- Patients with severe intraocular inflammation in the study eye
- Women who are pregnant, suspected of being pregnant or lactating
- Patients with known allergy to aflibercept
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Japan7 sites
Tsukazaki Hospital
Himeji, Hyōgo, 671-1227
Shimane University Hospital
Izumo, Shimane, 693-8501
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, 216-8511
Osaka University Hospital
Suita, Osaka, 565-0871
Takatsuki Red Cross Hospital
Takatsuki, Osaka, 569-1096
University of Fukui Hospital
Yoshida, Fukui, 910-1193
About this study
Official title: A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)
The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).
- Conditions
- Glaucoma, Neovascular
- Being tested
- Aflibercept (EYLEA, BAY86-5321), Topical IOP-lowering drugs
- 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
2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
Topical IOP-lowering drugsDrug
A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion
| Study group | Role | What they receive |
|---|---|---|
| NVG patients | Experimental | Japanese patients with neovascular glaucoma Receives: Drug: Aflibercept (EYLEA, BAY86-5321); Drug: Topical IOP-lowering drugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraocular Pressure (IOP) From Baseline to Week 1
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
Measured: Baseline and week 1
Secondary outcomes (1)
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
NVI Grade: 0=No iris neovascularization; 1=Fine surface neovascularization of the pupillary zone of the iris involving less than two quadrants; 2=Surface neovascularization of the pupillary zone of the iris involving more than two quadrants; 3=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving one to three quadrants; 4=In addition to neovascularization of the pupillary zone, neovascularization of the ciliary zone of the iris and/or ectropion uveae involving more than three quadrants. The change in NVI grades categorized to "Improved" means improvement by at least one grade from baseline.
Measured: Baseline and week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start3 Oct 2018
- Primary completion14 Feb 2019
- Study completion14 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, NeovascularStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639675
- Sponsor's protocol ID
- 19652
- Acronym
- VENERA
- Status last verified
- Feb 2020
- First submitted
- 17 Aug 2018
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Inatani M, Higashide T, Matsushita K, Nagasato D, Takagi H, Ueki M, Takai Y, Miyazaki K, Iwamoto Y, Kobayashi M, Leal S. Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study. Adv Ther. 2021 Feb;38(2):1106-1115. doi: 10.1007/s12325-020-01580-y. Epub 2020 Dec 16.
PubMed 33330959
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)
- ClinicalTrials.gov ID
- NCT03639675
- Acronym / sponsor ID
- VENERA / 19652
- Conditions
- Glaucoma, Neovascular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 3 Oct 2018 (actual)
- Primary completion
- 14 Feb 2019 (actual)
- Study completion
- 14 Mar 2019 (actual)
- First posted
- 21 Aug 2018 (actual)
- Results
- Posted 18 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The researchers in this trial want to learn how the drug aflibercept works in in Japanese patients with increased eye pressure that is caused by new blood vessels growing in the eye (neovascular glaucoma or NVG). They also want to find out how patient tolerate the application of the drug that is injected in the vitreous humor of the eye and if this will cause any medical problems during the trial (vitreous humor, also called vitreous body is the clear gel that fills the space between the lens and the retina of the eyeball).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVG patients | Experimental | Drug: Aflibercept (EYLEA, BAY86-5321), Drug: Topical IOP-lowering drugsJapanese patients with neovascular glaucoma |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Japanese men and women aged 20 years or older
- Patients diagnosed as having NVG (neovascular glaucoma) with neovascularization in the anterior segment (both iris and anterior chamber angle)
- Patients with IOP (intraocular pressure) higher than 25 mmHg in the study eye due to anterior segment (both iris and anterior chamber angle) neovascularization
Key exclusion criteria (5 listed)
- Patients with angle-closure due to conditions other than NVG or complete angle-closure due to NVG
- Patients with a known or suspected ocular or peri-ocular infection
- Patients with severe intraocular inflammation in the study eye
- Women who are pregnant, suspected of being pregnant or lactating
- Patients with known allergy to aflibercept
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)2 mg (0.05 mL), Intravitreal injection (IVT), single dose. | Drug | NVG patients |
| Topical IOP-lowering drugsA combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion | Drug | NVG patients |
Primary outcome
Change in Intraocular Pressure (IOP) From Baseline to Week 1
Time frame: Baseline and week 1
The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
1 secondary outcome
Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1
Time frame: Baseline and week 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33330959Inatani M, Higashide T, Matsushita K, Nagasato D, Takagi H, Ueki M, Takai Y, Miyazaki K, Iwamoto Y, Kobayashi M, Leal S. Efficacy and Safety of Intravitreal Aflibercept Injection in Japanese Patients with Neovascular Glaucoma: Outcomes from the VENERA Study. Adv Ther. 2021 Feb;38(2):1106-1115. doi: 10.1007/s12325-020-01580-y. Epub 2020 Dec 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aflibercept (EYLEA, BAY86-5321) and Topical IOP-lowering drugs in people with Glaucoma, Neovascular, run by Bayer at 7 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 5 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 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intraocular Pressure (IOP) From Baseline to Week 1 (time frame: Baseline and week 1). 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 NCT03639675, which also lists 1 linked publication.
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 3 Mar 2020.