HAWK Study for Wet Age-Related Macular Degeneration

HAWK Study for Wet Age-Related Macular Degeneration

Age-related macular degeneration (AMD) is a disease associated with aging that gradually destroys sharp, central vision. The form of advanced AMD being studied in this clinical trial is commonly referred to as wet AMD (also called neovascular or exudative AMD). Wet AMD occurs when abnormal blood vessels grow and leak below the retina (lightsensitive tissue lining the back of the eye), causing it to swell. The eye grows these abnormal blood vessels by producing a substance called vascular endothelial growth factor, or VEGF. Recently, doctors have found that injecting anti-VEGF drugs into the eye can help to reduce swelling of the retina and help to restore vision.

The purpose of this study is to find out what effect a new drug called RTH258 has on people with wet AMD. To do this, we will compare it to another anti-VEGF drug called Eylea® (generic name: aflibercept). RTH258 is still experimental and is not approved by the U.S. Food and Drug Administration. Eylea® is approved by the U.S. Food and Drug Administration for use in patients with this condition.

A total of about 990 people are expected to participate in this study worldwide, with up to 12 people at the Medical College of Wisconsin.

Participant Eligibility

Potential participants may qualify for the study if they meet all of the inclusion criteria and none of the exclusion criteria.

Inclusion criteria
-Wet AMD (will be confirmed by a study doctor).
-50 years of age or older.

Exclusion Criteria
-Previously received any treatment for Wet AMD, excluding vitamin supplements, in the study eye.
-Steroid injection in the study eye.
-Eye surgery in the study eye.
-Stroke or heart attack within the past 3 months.

Full Study Title
A Two-Year, Randomized, Double-Masked, Multicenter, Three-Arm Study Comparing the Efficacy and Safety of RTH258 versus Aflibercept in Subjects with Neovascular Age-Related Macular Degeneration

Study ID: NCT02307682

Study Sites
Medical College of Wisconsin- The Eye Institute

Principal Investigator(s)
Dr. William Wirostko, M.D.

Katie McKenney
(414) 955-7866


VersitiChildren's Hospital of WisconsinVA Medical CenterMarquette UniversityMSOEUWM