A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (TEN...

Enter your info and the study team will contact you soon!
Your data is securely stored and only shared with the research team
Logo Image
"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 50 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: macular degeneration, age-related macular degeneration, Neovascular Age-related Macular Degeneration
Type: Drug study, Phase 3
Target:
10 Participants
Investigator:
Description
This is a study of optional eye fluid (aqueous and vitreous humor) sample collection for patients in Study GR40306. This research is being done to test the effectiveness of the experimental study drug (faricimab).

The aqueous humor is the clear fluid in the front part of the eye. The vitreous humor is the jelly-like fluid in the back part of the eye. These eye fluids may reflect changes in the retina better than blood because they are close to the retina.

The samples will be analyzed for:
- concentrations of faricimab or aflibercept (the drugs used in this study)
- vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2), the proteins the drugs may target.

The remaining samples of blood, aqueous humor, and vitreous humor may be analyzed for other biomarkers.

These biomarkers include those involved in the growth of blood vessels, or inflammation in the eye over time. Analysis of these samples may be used to help identify new therapeutic targets.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Treatment-na├»ve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
  • Ability to comply with the study protocol, in the investigator's judgment
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
  • Other protocol-specified inclusion criteria may apply

Exclusion criteria:

  • Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
  • Pregnancy or breastfeeding, or intention to become pregnant during the study
  • CNV due to causes other than AMD in the study eye
  • Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
  • Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
  • Uncontrolled glaucoma in the study eye
  • Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
  • Prior IVT administration of faricimab in either eye
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye
  • Other protocol-specified exclusion criteria may apply
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study team will discuss the risks associated with taking part in this research study.
Compensation
You will be paid $50 for each visit at which an aqueous or vitreous sample is collected.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for 2 years.
Recruitment period
From July 16, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Wet Macular Degeneration