Glaucoma, NeovascularPhase 3VEGANCT02396316

Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients

A Phase 3 study testing Aflibercept (Eylea, BAY 86-5321) in people with Glaucoma, Neovascular, run by Bayer at 19 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

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma. 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, BAY 86-5321)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 54 participants
Where: 19 sitesJapan
Study dates: 2 Apr 2015to 6 Sep 2016
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 Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
Patients with Intraocular pressure (IOP) 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 Neovascular glaucoma
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

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

Japan19 sites

Study site
Amagasaki, Hyōgo, 660-8550
Study site
Bunkyo-ku, Tokyo, 113-8655
Study site
Chūō, Yamanashi, 409-3898
Study site
Gifu, Gifu, 501-1194
Study site
Himeji, Hyōgo, 671-1227
Study site
Hirakata, Osaka, 573-1191
Study site
Izumo, Shimane, 693-8501
Study site
Kanazawa, Ishikawa-ken, 920-8641
Study site
Kawasaki, Kanagawa, 216-8511
Study site
Kobe, Hyōgo, 650-0017
Study site
Kyoto, 602-0841
Study site
Mitaka, Tokyo, 181-8611
Study site
Osaka, 545-8586
Study site
Sendai, Miyagi, 980-8574
Study site
Suita, Osaka, 565-0871
Study site
Takatsuki, Osaka, 569-8686
Study site
Ube, Yamaguchi, 755-8505
Study site
Yoshida, Fukui, 910-1193
Study site
Yufu, Oita Prefecture, 879-5593

Other trials in Japan

About this study

Official title: A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

Conditions: Glaucoma, Neovascular
Being tested: Aflibercept (Eylea, BAY 86-5321), Sham Injection
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, BAY 86-5321)Drug
After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
Sham InjectionDrug
After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.

Study groups in NCT02396316
Study group	Role	What they receive
Aflibercept	Experimental	Aflibercept 2 mg Intravitreal (IVT) injection group Receives: Drug: Aflibercept (Eylea, BAY 86-5321)
Sham Injection	Sham comparator	Sham injection group Receives: Drug: Sham Injection

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 Pre-dose at Week 1
It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.
Measured: From baseline to pre-dose at Week 1

Secondary outcomes (1)

Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
NVI were assessed in the study eye using the NVI grading systems (grade 0 to grade 4). A subject who shows the improvement by at least one grade is considered to be improved. Percentage of subjects who had improved NVI grade was reported.
Measured: From baseline to pre-dose at Week 1

Timeline

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

2 Apr 20156 Sep 2016

First posted24 Mar 2015 (estimated)
Study start2 Apr 2015
Primary completion16 Jun 2016
Study completion6 Sep 2016

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 (2)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: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02396316
Sponsor's protocol ID: 17584
Acronym: VEGA
Status last verified: Aug 2017
First submitted: 18 Mar 2015
Last updated: 15 Sep 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.
PubMed 37010901
Inatani M, Higashide T, Matsushita K, Miki A, Ueki M, Iwamoto Y, Kobayashi M, Leal S; VEGA Investigators. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial. Adv Ther. 2021 Feb;38(2):1116-1129. doi: 10.1007/s12325-020-01579-5. Epub 2020 Dec 16.
PubMed 33330958

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingObservational study
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
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Active, not recruiting
Minimally Invasive Suprachoroidal Drainage for the Treatment of Neovascular Glaucoma
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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

All Glaucoma, Neovascular trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-masked, and Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of Intravitreal Administration of Aflibercept in Japanese Patients With Neovascular Glaucoma
ClinicalTrials.gov ID: NCT02396316
Acronym / sponsor ID: VEGA / 17584
Conditions: Glaucoma, Neovascular
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: BayerIndustry (pharma, biotech, devices)
Collaborators: Regeneron Pharmaceuticals
Study start: 2 Apr 2015 (actual)
Primary completion: 16 Jun 2016 (actual)
Study completion: 6 Sep 2016 (actual)
First posted: 24 Mar 2015 (estimated)
Results: Posted 21 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To assess the efficacy and safety of the administration of aflibercept by intravitreal injection in comparison to sham to control intraocular pressure in patients with neovascular glaucoma.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Aflibercept	Experimental	Drug: Aflibercept (Eylea, BAY 86-5321)Aflibercept 2 mg Intravitreal (IVT) injection group
Sham Injection	Sham comparator	Drug: Sham InjectionSham injection group

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 Neovascular glaucoma (NVG) with neovascularization in the anterior segment (both iris and anterior chamber angle),
Patients with Intraocular pressure (IOP) 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 Neovascular glaucoma
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, BAY 86-5321)After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.	Drug	Aflibercept
Sham InjectionAfter the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.	Drug	Sham Injection

Primary outcome

Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
Time frame: From baseline to pre-dose at Week 1
It compared the change in IOP from baseline to pre-dose at Week 1 between the aflibercept group vs the sham group.

1 secondary outcome

Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
Time frame: From baseline to pre-dose at Week 1

Results and safety

Results posted to the registry on 21 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aflibercept 2 mg Intravitreal (IVT) Injection Group	27	20
Sham Injection Group	27	22

Primary outcome: Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1

Time frame: From baseline to pre-dose at Week 1. Mean (Standard Deviation). Unit: mmHg

Measure	Aflibercept 2 mg Intravitreal (IVT) Injection Group n = 27	Sham Injection Group n = 27
Value	-8.5 (8.7)	-4.9 (10.8)

Aflibercept 2 mg Intravitreal (IVT) Injection Group vs Sham Injection Group: Difference of LS mean change: -4.9 (95% CI -10.2 to 0.3), p = 0.0644, ANCOVA

Population analysed: FAS: The Full Analysis Set (FAS) included all randomized subjects who have received any study drug (including sham injection) and had had a baseline and at least one post-baseline IOP measurement on a posterior date. The FAS was analyzed as randomized.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected after the first dose of study drug and no later than 30 days after the last dose of study drug. AEs from the first dose of study drug until pre-dose at Week 1 were also reported.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aflibercept 2 mg Intravitreal (IVT) Injection Group	3 of 27 (11.1%)	10 of 27 (37%)	Not reported
Sham Injection Group	3 of 27 (11.1%)	12 of 27 (44.4%)	Not reported
Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1)	0 of 27 (0%)	6 of 27 (22.2%)	Not reported
Sham Injection Group (Till Pre-dose at Week 1)	0 of 27 (0%)	7 of 27 (25.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37010901Rittiphairoj T, Roberti G, Michelessi M. Anti-vascular endothelial growth factor for neovascular glaucoma. Cochrane Database Syst Rev. 2023 Apr 3;4(4):CD007920. doi: 10.1002/14651858.CD007920.pub4.
Derived from this study: PubMed 33330958Inatani M, Higashide T, Matsushita K, Miki A, Ueki M, Iwamoto Y, Kobayashi M, Leal S; VEGA Investigators. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial. Adv Ther. 2021 Feb;38(2):1116-1129. doi: 10.1007/s12325-020-01579-5. Epub 2020 Dec 16.

Related trials for Glaucoma, Neovascular

RecruitingObservational study
Observation of Iris Blood Flow Via OCTA in Diabetic Neovascular Glaucoma
Neovascular Glaucoma, Type 2 Diabetes
RecruitingObservational study
Study to Learn More About Safety of Aflibercept Injection in Japanese Patients With Neovascular Glaucoma (NVG)
Neovascular Glaucoma
Active, not recruiting
Minimally Invasive Suprachoroidal Drainage for the Treatment of Neovascular Glaucoma
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Recruiting
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Active, not recruitingPhase 1
KDR2-2 Suspension Eyedrop in the Treatment of Neovascular Glaucoma (KDR-NVG) Trial
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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.

Bayer Study Director study director

Bayer

19 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, BAY 86-5321) in people with Glaucoma, Neovascular, run by Bayer at 19 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 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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. Some participants in this study may receive a placebo. 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 21 Jul 2017). 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 Pre-dose at Week 1 (time frame: From baseline to pre-dose at 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 NCT02396316, which also lists 2 linked publications.

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 15 Sep 2017.