Phase 3
N=54
Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
Glaucoma, Neovascular
Bottom Line
View on ClinicalTrials.gov: NCT02396316 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
Jul 2017
Primary outcome: Primary: Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 — -8.5; -4.9 mmHg — p=0.0644
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aflibercept (Eylea, BAY 86-5321) (Drug); Sham Injection (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 |
-8.5; -4.9 | 0.0644 |
| SECONDARY Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1 |
70.4; 11.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02396316). 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.