Phase 3
N=16
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
Glaucoma, Neovascular
Bottom Line
View on ClinicalTrials.gov: NCT03639675 ↗Enrolled (actual)
16
Serious AEs
6.3%
Results posted
Feb 2020
Primary outcome: Primary: Change in Intraocular Pressure (IOP) From Baseline to Week 1 — -8.3 mmHg — p=0.0004
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (EYLEA, BAY86-5321) (Drug); Topical IOP-lowering drugs (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) From Baseline to Week 1 |
-8.3 | 0.0004 sig |
| SECONDARY Percentage of Participants Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Week 1 |
13 | — |
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). 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).
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT03639675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.