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.

Ocular implant (LADDER Study) for wet macular degeneration

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 is recruiting newly diagnosed wet AMD patients age 50 or older who meet other eligibility criteria. 

Contact: Ann Lundquist, 503 494-6364

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. The study is recruiting people age 65 and older with advanced macular degeneration as well as those without the disease who meet other criteria.

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

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 are being followed.

Lampalizumab for advanced dry AMD (SPECTRI, CHROMA and OMASPECT)

Purpose: To evaluate the effectiveness and safety of lampalizumab in patients with geographic atrophy (GA), an advanced form of dry AMD. The medication, given by injection into the eye, targets an enzyme that may encourage dry AMD to develop. The studies are examining changes in vision and the area of GA.

In the two parent studies, SPECTRI and CHROMA, participants are treated with either the experimental medication or sham treatment. Both the study patients and researchers are unaware of the treatment assignment. Enrollment in these studies is completed and patients are being followed. Those who complete all of their study visits can enroll into an extension study called OMASPECT. This clinical trial is open-label, meaning all participants will receive lampalizumab.

BEACON Study (Implantable medication for dry AMD)

Purpose: To learn if an implantable medication, Brimonidine, is safe and effective for treating geographic atrophy (GA), an advanced form of dry AMD. Brimonidine, used in eye drop form to treat glaucoma, has been shown to protect cells in the retina. In this Phase 2 study, a tiny pellet was implanted into the eye's vitreous that releases the medication to the retina over a sustained period of time. Enrollment is completed and study patients are being followed.