Clinical trial NCT02396316: Japanese Phase 3 Study of Aflibercept in Neovascular Glaucoma Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glaucoma, Neovascular
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2015-03-24
Enrollment: 54
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1
timeFrame: From baseline to pre-dose at Week 1
Secondary outcomes:
measure: Percentage of Subjects Who Had Improved Neovascularization of the Iris (NVI) Grade From Baseline to Pre-dose at Week 1
timeFrame: From baseline to pre-dose at Week 1
Other outcomes:
Locations:
city: Yoshida
country: Japan
state: Fukui
city: Amagasaki
country: Japan
state: Hyogo
city: Himeji
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Kanazawa
country: Japan
state: Ishikawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Yufu
country: Japan
state: Oita
city: Hirakata
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Izumo
country: Japan
state: Shimane
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Mitaka
country: Japan
state: Tokyo
city: Ube
country: Japan
state: Yamaguchi
city: Chuo
country: Japan
state: Yamanashi
city: Gifu
country: Japan
city: Kyoto
country: Japan
city: Osaka
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Inatani M, Higashide T, Matsushita K, Miki A, Ueki M, Iwamoto Y, Kobayashi M, Leal S; VEGA Investigators. Intravitreal Aflibercept in Japanese Patients with Neovascular Glaucoma: The VEGA Randomized Clinical Trial. Adv Ther. 2021 Feb;38(2):1116-1129. doi: 10.1007/s12325-020-01579-5. Epub 2020 Dec 16.