by Daniel Parker, RDPFS Contributor:
Two clinical trials to test the efficacy of an investigational eye drop called KHK4951 have recently begun recruiting participants with vision loss. Study 4951-002 concerns the drop’s effectiveness in treating neovascular age-related macular degeneration (NAMD) which occurs when newly formed blood vessels leak under the part of the retina known as the macula. By contrast, study 4951-003 assesses the eye drop’s potential for treating diabetic macular edema (DME), where blood vessels leak under the macula in people with diabetes. Both conditions can lead to vision loss. The new drop is designed to inhibit formation and leakage of these blood vessels. The studies employ a prescreening at one of 86 testing centers, 39 in the U.S., where it is determined if either condition exists. If the potential participant is over age 50 for the NAMD study or over age 18 for the DME study, and is not currently undergoing treatment, they will begin the first of two phases. In both trials, a drug already approved to treat these diseases, called Aflibercept, is injected in varying doses depending on the study. Following this phase comes a four-week follow-up period. A notable exclusion criterion for both experiments is uncontrolled glaucoma in the study eye, and the DME trial also excludes those who have signs of proliferative diabetic retinopathy in the study eye. Those who are interested in participating are advised to speak with their ophthalmologist. Much more information can be found on the U.S. Clinical Trials website here for the NAMD study and here for the DME study.
