Trial Condition(s):
Glaucoma, Neovascular
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 (VENERA)
Bayer Identifier:
19652
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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).
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations University of Fukui Hospital Yoshida, Japan, 910-1193 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Tsukazaki Hospital Himeji, Japan, 671-1227 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Osaka University Hospital Suita, Japan, 565-0871 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Takatsuki Red Cross Hospital Takatsuki, Japan, 569-1096 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations St. Marianna University School of Medicine Hospital Kawasaki, Japan, 216-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Kanazawa University Hospital Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Shimane University Hospital Izumo, Japan, 693-8501 | Status Completed | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Change in intraocular pressure (IOP) from baseline to Week 1The primary efficacy analysis was on the changes in IOP from baseline to Week 1 (LOCF).Timeframe: Baseline and week 1
Secondary Outcome
- Percentage of participants who had improved neovascularization of the iris (NVI) grade from baseline to Week 1NVI 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.Timeframe: Baseline and week 1
Additional Information
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