Ongoing clinical trials for AMD at Casey Eye Institute
Metformin for dry macular degeneration
Purpose: To determine whether oral Metformin HCL (a diabetes medication) is an effective treatment for slowing the progression of geographic atrophy (late form of dry AMD) in patients with dry age-related macular degeneration (AMD). Qualified study patients will be enrolled in a randomized study that lasts 18 months and requires four study visits at Casey Eye Institute. Eligible participants must be age 55 or older and have advanced dry AMD in one or both eyes. Candidates cannot have diabetes or currently be taking Metformin. Other eligibility criteria may also apply.
Contact: Jennifer Maykoski, 503-494-3064.
Genetics of Age-Related Macular Degeneration Study
Purpose: To find genetic mechanisms associated with AMD, which will lead to more accurate early detection and precise treatments. Researchers are using advanced whole genome sequencing technology to find gene variations in large families and other populations affected by AMD. The study is supported in part by a major grant from the National Eye Institute.
Contact: Jennifer Maykoski, 503 494-3064
Advanced imaging trials
Purpose: To test the capabilities of high-speed optical coherence tomography (OCT) in patients with dry or wet AMD. OCT uses light waves to produce extremely detailed cross-sectional images of eye structures. Investigators are studying whether this new version of OCT can visualize and measure blood vessel growth as well as fluorescein angiography, which involves the injection of a contrasting agent to highlight the problem vessels. The team is also comparing how retinal anatomy and blood flow differ among study patients in early, intermediate and advanced dry AMD.
Contact: Denny Romfh, 503 494-4351 or Omkar Thaware, 503 494-7398
Diet and vision study (Carotenoids in Age-Related Eye Disease Study 2)
Purpose: To learn whether the levels of pigment in the eye’s macula is a risk marker for the development of AMD and loss of retina function with age. The study is also evaluating whether macular pigment declines with age and if so, what factors play a role. Macular pigment is made up of the nutrients lutein and zeaxanthin, which are highly concentrated in healthy retinas. These nutrients, known as carotenoids, are found in green, yellow and orange fruits and vegetables. Macular pigment may protect the macula by acting as an anti-oxidant and absorbing harmful blue light.
CAREDS 2 is an offshoot of the national Women’s Health Initiative (WHI), which has tracked the health of post-menopausal women since 1991. The study is limited to participants in the original CAREDS and involves gathering information about health and lifestyle habits, testing blood serum and macular pigment levels, and taking retina photos.
Contact: Jennifer Maykoski, 503 494-3064
Studies with completed enrollment
Association between advanced AMD and alterations in the gut microbiome
Purpose: To learn whether associations exist between gastrointestinal tract gut bacteria and advanced AMD. Researchers will also explore the connection between an individual's genes and the activity of the gut bacteria. Study participants include people with advanced macular degeneration as well as those without the disease who met other criteria. Enrollment is completed and these study patients are being followed.
Ocular implant for wet macular degeneration (LADDER Study)
Purpose: To compare the effects of an ocular implant that releases one of three different doses of ranibizumab (Lucentis) to injections of ranibizumab. The study implant releases the study drug continuously for a prolonged period of time and can be refilled by your doctor when needed. This approach may decrease the need for frequent injections into the eye. This Phase 2 study has completed enrollment and patients are being followed.
Injectable medication for wet AMD (SEQUOIA Study)
Purpose: To compare the safety and effectiveness of the study drug abicipar pegol to ranibizumab (Lucentis) in patients with an eye newly diagnosed with wet AMD. Abicipar pegol is an anti-VEGF agent that may be more long lasting than some current therapies for wet AMD. Enrollment is this Phase 3 study is completed and study patients are being followed.
Gene therapy for wet AMD (GEM Study)
Purpose: To assess the safety and dosing levels of a gene-based treatment, RetinoStat, for wet AMD. In this Phase 1 study, two helpful genes are delivered directly to the retina, where they "turn on" proteins that block abnormal blood vessel growth in a sustained fashion. Enrollment is completed and study patients continue to be followed.