Trial Condition(s):
Glaucoma, Neovascular
Japanese phase 3 study of Aflibercept in Neovascular glaucoma patients (VEGA)
Bayer Identifier:
17584
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
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.
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yoshida, Japan, 910-1193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kyoto, Japan, 602-0841 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suita, Japan, 565-0871 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Osaka, Japan, 545-8586 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Takatsuki, Japan, 569-8686 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hirakata, Japan, 573-1191 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yufu, Japan, 879-5593 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Mitaka, Japan, 181-8611 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izumo, Japan, 693-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Ube, Japan, 755-8505 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Sendai, Japan, 980-8574 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bunkyo-ku, Japan, 113-8655 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Chuo, Japan, 409-3898 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Gifu, Japan, 501-1194 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kawasaki, Japan, 216-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kobe, Japan, 650-0017 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Himeji, Japan, 671-1227 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Amagasaki, Japan, 660-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
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
Primary Outcome
- Change in Intraocular pressure (IOP) from baseline to pre-dose at Week 1Timeframe: Baseline and Week 1
Secondary Outcome
- Proportions of subjects who have improved Neovascularization of the iris (NVI) grade from baseline to Week 1A subject who shows the improvement by at least one grade is considered to be improved.Timeframe: Baseline and Week 1
Additional Information
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