CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 16 enrolled
Drug / intervention
Aflibercept (EYLEA, BAY86-5321) +1 moredrug
Likely dose
Aflibercept (EYLEA, BAY86-5321) 2 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03639675
NCT03639675Phase 3Completed

A Single-arm, Non-randomized and Open-label Phase 3 Study Evaluating the Efficacy, Safety and Tolerability of Intravitreal Aflibercept in Japanese Patients With Neovascular Glaucoma (NVG)

Bayer·interventional·Posted Aug 21, 2018·Updated Mar 3, 2020

In Brief

A Phase 3 clinical trial evaluating Aflibercept (EYLEA, BAY86-5321) and Topical IOP-lowering drugs for Glaucoma, Neovascular. Completed, enrolled 16 participants across 7 sites.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesJapan

Timeline

Phase 3CompletedFinished
20192020202120222023202420252026
First PostedAug 21, 2018
Enrollment StartOct 3, 2018
Primary CompletionFeb 14, 2019
Study CompletionMar 14, 2019
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 7.9 years ago

Interventions

Aflibercept (EYLEA, BAY86-5321)drug

2 mg (0.05 mL), Intravitreal injection (IVT), single dose.

Topical IOP-lowering drugsdrug

A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion