IRB Study Number 24-056
Status Recruiting
Location i Building - Cole Eye Institute
Institute Cole Eye Institute
Description
The purpose of this study is to find out if periodic injections in the eye of faricimab or an Iluvien implant is better for vision than initial observation (watching until disease develops) in people who are at risk for radiation retinopathy. Radiation retinopathy is a complication that can occur after radiation therapy for cancer in the back of the eye. This study specifically looks at chorodial melanoma treated with radiation retinopathy. If retinopathy develops, it is often not seen until many months after radiation treatment. Eyes with radiation retinopathy are at high risk for developing reduced blood flow in the retina and swelling in the most important portion of the retina that is responsible for good vision, known as the macula. When swelling in the macula occurs, it is called macular edema. Most eyes are only observed after radiation therapy unless macular edema develops that can affect vision. If macular edema develops, it is often treated with injections of an anti-VEGF drug or a corticosteroid. However, these treatments do not always stop vision loss. Therefore, the study will see if there is a difference in vision loss at 3 years when injections are started early compared with waiting to treat.
This research study will last for about 3 years. During that time, visits will occur every three months. The visits will include the following procedures at some point throughout the study: Vision testing, Eye exam, Photographs of the eye, and Treatment. The treatment arms include injections in your eye of either faricimab or Iluvien or you will be observed (or watched with no treatment). The study participant will know which treatment they are getting. If macular edema develops you will receive additional treatment with faricimab or Iluvien.
Inclusion Criteria
In general, to take part in this study, you ++must++:
· Be 18 years of age or older
· Have at least one eye with cancer that meets certain criteria:
o standard of care treatment of the cancer with radiation therapy
o minimum dose of radiation to the central part of your retina (the macula)
o the cancer does not directly involve the center part of your retina (macula) or the optic disc (nerve that connects the eye to the brain)
o no prior history of increased eye pressure
o no diabetic eye disease above a certain level
o no prior treatment with an anti-VEGF drug
o no treatment within the prior 90 days with a corticosteroid
o no increase in eye pressure over a certain level after steroid treatment following the radiation therapy
Exclusion Criteria
Also, you ++must not++:
· Have taken part in a study in which you received an investigational treatment within last 30 days
· Have any known allergy to any component of the study drug or any drug used in the injection prep (like povidone iodine prep)
· Be actively receiving systemic (oral or IV) steroid, anti-VEGF or pro-VEGF treatment or plan to receive any of these during the study
Be pregnant or intending to become pregnant in the three years or nursing an infant. If you are a woman who has the potential to become pregnant, you must use a reliable birth control method during the study and for 3 months after your last dose of study treatment. Talk with your study doctor about what method may be best for you. Be certain to tell us if there is any possibility you could be pregnant, and we will obtain a pregnancy test. Tell your study doctor right away if you get pregnant. If you get pregnant, the study doctor will want to follow-up with you until the outcome of the pregnancy is known.
