drugset / 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 16 enrolled Bayer Regeneron Pharmaceuticals · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2018-10-03
Primary completion
2019-02-14
Completion
2019-03-14

Outcome

Met primary endpoint

paper The mean IOP decreased from 34.1 mmHg at baseline to 25.8 mmHg at week 1 (mean change, -8.3 mmHg [95% confidence interval; CI -12.2 to -4.4; P = 0.0004]). PMID 33330959 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aflibercept Protein / enzyme biologic 2 mg Intravitreal

Indications