- If you qualify for and participate in the study, you will be randomly assigned to receive either the investigational drug or placebo via subcutaneous injection into the skin.
- To help keep the study results as accurate as possible, you, the doctor, and staff conducting the study will not know if you are being given the investigational drug or the placebo (unless there is an emergency).
- Your total participation in the study will be for approximately 71 weeks (18 months), including screening for eligibility, study treatment, and follow-up.
- During the first 3 weeks of the study treatment period, you will receive two injections of the study drug. After that, you will receive an injection of the study drug every month for the next 42 weeks.
To pre-qualify for GOLDEN, you must:
- Be at least 50 years of age
- Have a medical diagnosis of AMD in at least one eye
- Have GA in that same eye
In addition to the requirements above, other tests and information will be required to determine your eligibility.
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The purpose of the GOLDEN study is to determine if the potential new treatment, or “investigational drug” is safe and effective in slowing the progression of GA caused by AMD.
- Geographic atrophy (GA) is a late stage of age-related macular degeneration (AMD) and occurs when cells in the retina deteriorate and die, resulting in blind spots in the visual fields.
- The investigational antisense drug (or placebo) will be administered via subcutaneous injection beneath the skin in the abdomen or thigh—not into the eye. Because of this, there is the potential to treat both eyes with just one single injection.