check_circleStudy Completed

Glaucoma, Neovascular

Bayer Identifier:

19652

ClinicalTrials.gov Identifier:

NCT03639675

EudraCT Number:

Not Available

EU CT Number:

Not Available
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

Trial purpose

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).

Key Participants Requirements

Sex

All

Age

20 - N/A
  • - 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
  • - 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

Trial summary

Enrollment Goal
16
Trial Dates
October 2018 - March 2019
Phase
Phase 3
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
University of Fukui HospitalYoshida, 910-1193, Japan
Withdrawn
Kyoto Prefectural University of MedicineKyoto, 602-8566, Japan
Completed
Tsukazaki HospitalHimeji, 671-1227, Japan
Completed
Osaka University HospitalSuita, 565-0871, Japan
Completed
Takatsuki Red Cross HospitalTakatsuki, 569-1096, Japan
Completed
St. Marianna University School of Medicine HospitalKawasaki, 216-8511, Japan
Completed
Kanazawa University HospitalKanazawa, 920-8641, Japan
Withdrawn
Yamaguchi University HospitalUbe, 755-8505, Japan
Withdrawn
Kyorin University HospitalMitaka, 181-8611, Japan
Completed
Shimane University HospitalIzumo, 693-8501, Japan

Primary Outcome

  • Change in intraocular pressure (IOP) from baseline to Week 1
    The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).
    date_rangeTime Frame:
    Baseline and week 1

Secondary Outcome

  • Percentage of participants who had improved neovascularization of the iris (NVI) grade from baseline to 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.
    date_rangeTime Frame:
    Baseline and week 1

Trial design

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)
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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