Trial · NCT02396316
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
NCT02396316, Phase 3, Completed, Bayer; results first posted 2017-07-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients. Trials, record NCT02396316. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02396316
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
- NCT number
- NCT02396316
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 54 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Glaucoma, Neovascular
- Interventions
- Aflibercept (Eylea, BAY 86-5321), Sham Injection
- First posted
- 2015-03-24
- Last updated
- 2017-09-15
- Results first posted
- 2017-07-21
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 | 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. |
| Secondary | Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 | From baseline to pre-dose at Week 1 | 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. | mmHg | MEAN |
| SECONDARY | Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | From baseline to pre-dose at Week 1 | FAS | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | -8.5 | Standard Deviation 8.7 | mmHg | |
| Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 | Sham Injection Group | -4.9 | Standard Deviation 10.8 | mmHg | |
| Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 70.4 | Percentage of participants | ||
| Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 | Sham Injection Group | 11.5 | Percentage of participants |
Source ClinicalTrials.gov
Participant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 27 | |
| Overall Study | STARTED | Sham Injection Group | 27 | |
| Overall Study | Treated | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 27 | |
| Overall Study | Treated | Sham Injection Group | 27 | |
| Overall Study | Received Sham Injection at Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 10 | |
| Overall Study | Received Sham Injection at Week 1 | Sham Injection Group | 0 | |
| Overall Study | Received AFL Injection at Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 0 | |
| Overall Study | Received AFL Injection at Week 1 | Sham Injection Group | 22 | |
| Overall Study | Received Active Injection at Week 5 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 4 | |
| Overall Study | Received Active Injection at Week 5 | Sham Injection Group | 4 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival haemorrhage | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 2 | 27 | 2 |
| other | Conjunctival haemorrhage | Eye disorders | Sham Injection Group | 1 | 27 | 1 |
| other | Conjunctival haemorrhage | Eye disorders | Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) | 2 | 27 | 2 |
| other | Conjunctival haemorrhage | Eye disorders | Sham Injection Group (Till Pre-dose at Week 1) | 0 | 27 | 0 |
| other | Eye pain | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 0 | 27 | 0 |
| other | Eye pain | Eye disorders | Sham Injection Group | 4 | 27 | 5 |
| other | Eye pain | Eye disorders | Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) | 0 | 27 | 0 |
| other | Eye pain | Eye disorders | Sham Injection Group (Till Pre-dose at Week 1) | 1 | 27 | 1 |
| other | Hyphaema | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 0 | 27 | 0 |
| other | Hyphaema | Eye disorders | Sham Injection Group | 2 | 27 | 2 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept 2 mg Intravitreal (IVT) Injection Group | ||
| Total, all-cause mortality | Sham Injection Group | ||
| Total, all-cause mortality | Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) | ||
| Total, all-cause mortality | Sham Injection Group (Till Pre-dose at Week 1) | ||
| Total, other adverse events | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 10 | 27 |
| Total, other adverse events | Sham Injection Group | 12 | 27 |
| Total, other adverse events | Aflibercept 2 mg IVT Injection Group (Till Pre-dose at Week 1) | 6 | 27 |
| Total, other adverse events | Sham Injection Group (Till Pre-dose at Week 1) | 7 | 27 |
| Total, serious adverse events | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 3 | 27 |
| Total, serious adverse events | Sham Injection Group | 3 | 27 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02396316
GET https://conductscience.org/api/trials/v1/NCT02396316/events?page=2