Trial · NCT03639675
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
NCT03639675, Phase 3, Completed, Bayer; results first posted 2020-02-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. 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. Trials, record NCT03639675. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03639675
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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
- NCT number
- NCT03639675
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 16 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Glaucoma, Neovascular
- Interventions
- Aflibercept (EYLEA, BAY86-5321), Topical IOP-lowering drugs
- First posted
- 2018-08-21
- Last updated
- 2020-03-03
- Results first posted
- 2020-02-18
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 Week 1 | Baseline and week 1 | The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF). |
| Secondary | Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 | Baseline and 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. |
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 Week 1 | Baseline and week 1 | mmHg | MEAN | |
| SECONDARY | Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 | Baseline and week 1 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group2
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 Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | -8.3 | Standard Deviation 7.3 | mmHg | |
| Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 13 | Participants |
Source ClinicalTrials.gov
Participant flow4
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 | 16 | |
| Overall Study | Received Treatment | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 16 | |
| Overall Study | COMPLETED | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 15 | |
| Overall Study | NOT COMPLETED | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 |
Source ClinicalTrials.gov
Adverse events7
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 | Corneal erosion | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
| other | Eye pain | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 4 | 16 | 4 |
| other | Eye pruritus | Eye disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
| other | Nasopharyngitis | Infections and infestations | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
| other | Pneumonia | Infections and infestations | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
| other | Headache | Nervous system disorders | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
| serious | Pneumonia | Infections and infestations | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 0 | 16 |
| Total, other adverse events | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 6 | 16 |
| Total, serious adverse events | Aflibercept 2 mg Intravitreal (IVT) Injection Group | 1 | 16 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33330959 | DERIVED |
Source PubMed
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/NCT03639675
GET https://conductscience.org/api/trials/v1/NCT03639675/registered