A Study of Experimental Sunitinib Malate (GB-102) Compared to Aflibercept For Wet Age-Related Macular Degeneration
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Age: 50 years or older
Gender:
Any
Healthy Volunteers: No
Keywords: Neovascular (Wet) Age-related Macular Degeneration, wet macular degeneration, macular degeneration, vision changes
Type: Drug study, Phase 2
Target:
5 Participants
Investigator:
Description
This study will test an experimental drug called “GB-102.” It is being tested as treatment for wet (neovascular) age-related macular degeneration (AMD).

The purpose of this study is to collect more information about the safety and tolerability of multiple injections (up to six) of GB-102. We hope to find out how long and how well GB-102 works in treating people with wet AMD. Wet AMD is a disease in which abnormal new blood vessels grow in the retina (the back of the eye), which causes leakage of fluid and loss of vision.

GB-102 is expected to stop the leakage of fluid and prevent further growth of these abnormal vessels. This helps to maintain or improve vision. GB-102 is a slow-releasing formula of a drug called sunitinib malate. Sunitinib malate has been approved by the FDA for use orally (by mouth) for the treatment of certain types of kidney, stomach, and pancreatic cancers.

The current standard of care for the treatment of wet AMD is an injection (given into the eye) of antivascular endothelial growth factor (anti-VEGF). Anti-VEGF is a class of drug that helps stop new blood vessels from leaking and growing. However, anti-VEGF injections need to be given frequently, which can make treatment difficult to accommodate and costly for those who require them.

These injections are done intravitreally, which requires a needle to deliver the drug into the back of the eye. GB-102 is designed to stay in the back of the eye, where it is injected, and be released and absorbed slowly into the eye over several months. The goal is to reduce how often an injection into the eye is needed.

This study will also provide information about the dose of GB-102 that should be used for the treatment of wet AMD. Two different doses (1 mg and 2 mg) of GB-102 will be used in this study. The doses of GB-102 will be compared to a 2 mg dose of a medicine called EYLEA® (also called “aflibercept”). EYLEA is a medicine that is already approved in the United States for the treatment of wet AMD.
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:

  • Males or females ≥ 50 years of age
  • Presence of a CNV lesion secondary to AMD treated with at least 3 prior IVT injections of an anti-VEGF agent (aflibercept, bevacizumab, or ranibizumab).
  • Demonstrated response to prior anti-VEGF treatment since diagnosis
  • BCVA of 35 letters or better

Exclusion criteria:

  • History, within 6 months prior to screening, of any of the following: myocardial infarction, any cardiac event requiring hospitalization, treatment for acute congestive heart failure, transient ischemic attack, or stroke
  • Uncontrolled hypertension, diabetes mellitus or IOP
  • Chronic renal disease
  • Abnormal liver function
  • Women who are pregnant or lactating
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
If you agree to take part in this research study, we will compensate you for your time and effort. You will receive $125.00 for each study visit completed. Your payment will be based on the actual number of visits completed. Payments will be made quarterly, in the form of a check sent to you at the mailing address on file.
Resources
Schedule
Study duration and period
We expect that you will be in this research study for about 13 months and will involve 15 visits.
Recruitment period
From July 22, 2019
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Research Topic
Conditions:
  • Neovascular Age-Related Macular Degeneration

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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