PARIS — Partnering with Fight for Sight, the European Society of Retina Specialists will award a 2 million euros grant to a research project addressing the best treatment option for submacular hemorrhage secondary to wet age-related macular degeneration.
In a randomized trial, surgical management involving vitrectomy, subretinal injection of tissue plasminogen activator and intravitreal gas injection of SF6 will be compared with anti-VEGF monotherapy with Eylea (aflibercept, Regeneron/Bayer).
The surgery aims at dissolving and then mechanically displacing the submacular hemorrhage.
“There is a clinical impression that surgery is worthwhile, but we need the evidence,” Timothy Jackson, PhD, FRCOphth, said in an interview with Healio.com/OSN at the Euretina meeting. “There are surgical risks in doing vitrectomy, and this factor may have more of an impact than we realize, so this trial aims to establish the risk and benefits of surgery vs. anti-VEGF monotherapy.”
The study will involve 65 to 70 centers in Europe and is expected to be completed within approximately 5 years. The primary outcome is a gain of 10 ETDRS letters of best corrected visual acuity at 12 months. Enrollment is the first and biggest challenge because submacular hemorrhage secondary to AMD is a relatively rare condition.
“Several centers have already teamed up in the project, but we need more. Once the regulatory requirements are fulfilled, we should be able to start, probably in spring next year,” Jackson said.
The grant was allocated on a competitive basis, partnering with Fight for Sight. The investment of Euretina was crucial in this project because a rare condition such as submacular hemorrhage secondary to AMD would not attract commercial investors.
“This is a clinical trial that would never have taken off without Euretina’s support. It is not something that is intrinsically interesting to industry, and a drug, used off license, is already available,” Jackson said.
Jackson is a professor of retinal research and consultant ophthalmic surgeon at King’s College in London. Funding a research project based in the U.K. may encounter complications due to the impending Brexit conditions, Euretina president Sebastian Wolf, MD, PhD, said when announcing the winning applicant at the meeting.
“We are hopeful that these complications will be successfully overcome,” he said. – by Michela Cimberle
For more information:
Timothy Jackson, PhD, FRCOphth , can be reached at Department of Ophthalmology, King’s College Hospital, Denmark Hill, Brixton, London SE5 9RS; email: firstname.lastname@example.org.
Disclosure: Jackson reports no relevant financial disclosures.