Prophylactic Intraoperative Adjuvant Therapy with 5-Fluorouracil and Low Molecular Weight Heparin for the Prevention of Proliferative Vitreoretinopathy (PVR) in High-risk Patients with Primary Rhegmatogenous Retinal Detachment.

• Applicant: Privatdozentin Dr. Friederike Schaub, since 8/2019
• Subject Area: Ophthalmology
• Term: from 2015 to 2021
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 264589742

Proliferative vitreoretinopathy (PVR) is the major cause for postoperative failure after surgery for rhegmatogenous retinal detachment (RRD). Fibrovascular scars lead to secondary retinal detachments, which often require multiple extensive operations to achieve re-attachment. Despite advances in the surgical management of PVR, the visual prognosis is poor and many patients become legally blind. Although several studies using chemotherapeutic agents have been undertaken, so far there is no standard therapy to prevent PVR. Two independent trials used an intravitreal infusion with 5-Fluorouracil (5-FU) plus low molecular weight heparin (LMWH) during surgery once in high-risk patients and once in unselected patients. In high-risk patients 5-FU + LMWH reduced PVR rates by 50%, while in unselected patients it did not. A review of the COCHRANE-collaboration led to the recommendation to conduct a clinical randomized trial using 5-FU + LMWH in high-risk patients. We have established non-invasive laser flare photometry as a novel tool for fast and precise estimation of the risk for PVR re-detachments. By selecting high-risk patients with this method we plan to use intraoperative intravitreal 5-FU + LMWH as a prophylactic therapy in a placebo controlled, randomized, double blind trial. We aim to reduce the incidence of PVR in the treatment group. 5-FU + LMWH would be the first effective prophylactic standard treatment to prevent PVR and decrease the incidence of blindness in patients with retinal detachments. Laser flare photometry would limit the treatment to those at high risk.

• DFG Programme: Clinical Trials
• Participating Person: Dr. Robert Hörster
• Ehemalige Antragsteller: Professor Dr. Sascha Fauser, until 3/2016; Professor Dr. Bernd Kirchhof, from 4/2016 until 7/2019