check_circleStudy Completed

Glaucoma, Neovascular

Bayer Identifier:

17584

ClinicalTrials.gov Identifier:

NCT02396316

EudraCT Number:

Not Available

EU CT Number:

Not Available
Japanese phase 3 study of Aflibercept in Neovascular glaucoma patients

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

20 - N/A
  • - 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.

  • - 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.

Trial summary

Enrollment Goal
54
Trial Dates
April 2015 - September 2016
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
Kanazawa, 920-8641, Japan
Completed
Yoshida, 910-1193, Japan
Completed
Kyoto, 602-0841, Japan
Completed
Suita, 565-0871, Japan
Terminated
Osaka, 545-8586, Japan
Completed
Takatsuki, 569-8686, Japan
Completed
Hirakata, 573-1191, Japan
Completed
Yufu, 879-5593, Japan
Completed
Mitaka, 181-8611, Japan
Completed
Izumo, 693-8501, Japan
Completed
Ube, 755-8505, Japan
Completed
Sendai, 980-8574, Japan
Completed
Bunkyo-ku, 113-8655, Japan
Completed
Chuo, 409-3898, Japan
Terminated
Gifu, 501-1194, Japan
Completed
Kawasaki, 216-8511, Japan
Completed
Kobe, 650-0017, Japan
Completed
Himeji, 671-1227, Japan
Completed
Amagasaki, 660-8550, Japan

Primary Outcome

  • Change in Intraocular pressure (IOP) from baseline to pre-dose at Week 1
    date_rangeTime Frame:
    Baseline and Week 1
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    Safety Issue:
    No

Secondary Outcome

  • Proportions of subjects who have improved Neovascularization of the iris (NVI) grade from baseline to Week 1
    A subject who shows the improvement by at least one grade is considered to be improved.
    date_rangeTime Frame:
    Baseline and Week 1
    enhanced_encryption
    Safety Issue:
    No

Trial design

A randomized, double-masked, and controlled phase 3 study to evaluate the efficacy, safety, and tolerability of intravitreal administration of aflibercept in Japanese patients with neovascular glaucoma
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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