Clinical trials are research studies designed to provide information to doctors about whether medical treatments, like drugs or new devices, work. Furthermore, these trials help researchers uncover cures for conditions.

NYSCF-funded research is pioneering groundbreaking stem cell therapies for clinical use, such as one to repair retinal damage and restore vision. Read this article to gain more information.

AREDS

Age-Related Eye Disease Study (AREDS) concluded that taking antioxidant vitamins and minerals could significantly decrease the risk of macular degeneration progression, through randomized clinical trial testing high dose supplements with vitamins C and E, beta carotene, zinc and other ingredients such as lutein or zeaxanthin or omega-3 long chain polyunsaturates to the original formulation reduced it further. Its major conclusion led to two additional trials: AREDS2 and CATT, the latter investigating whether supplementing with these additional ingredients reduced progression risks as AREDS formulation was applied – with results showing reduction of progression rates with regard to late AMD progression risk reduction compared with controls in late AMD patients compared with standard formulation alone.

AREDS research team found that taking specific combination of nutrients reduced risk of moderate to advanced macular degeneration by about 25%. Their 2021 publication of the AREDS2 study demonstrated how including lutein, zeaxanthin, omega-3 long-chain polyunsaturates fats in their formulation also helped lower risk.

Macular degeneration causes vision loss by damaging a small area at the center of retina known as macula, disrupting central vision (such as reading or driving a car). There are two forms of macular degeneration – dry and wet. Ninety-five to 99 percent of cases can be classified as dry macular degeneration and involve the buildup of deposits known as drusen that slowly accumulate behind the retina, eventually leading to central vision degradation over time. Ten to fifteen percent of patients develop wet macular degeneration, which involves abnormal blood vessels leaking fluid onto retina, leading to more severe vision loss than dry form of disease.

Treating wet macular degeneration with laser photocoagulation to destroy new blood vessels and prevent leakage and bleeding is one approach, while several medications can help slow progression and improve visual acuity.

Clinical trials require standard measures in order to accurately evaluate potential treatments. Unfortunately, it was once difficult to compare macular degeneration studies due to large variations in prevalence rates reported. The figure above depicts estimated prevalence rates from 16 studies that reported overall rates. Its high degree of variability likely reflects differences in methodology, disease definition and population characteristics.

After the AREDS study was concluded, participants in another investigation (AREDS2) were monitored over five years to see if they developed either neovascular AMD or central geographic atrophy (CGA). The second AREDS2 investigation confirmed that using the AREDS formulation decreased risk for advanced AMD by about 25%.

AREDS2 added two supplements – lutein/zeaxanthin and omega-3 long-chain polyunsaturates (DHA/EPA) – to the original AREDS formula; however, studies showed that their addition did not reduce progression to late AMD.

The AREDS3 study is tracking the progression of neovascular AMD and CGA among participants from AREDS2, with results expected in 2022. CPOB staff are providing support to its Coordinating Center and Photograph Reading Center as part of this investigation.