Prophylactic 5-FU plus heparin not effective against proliferative vitreoretinopathy in RRD

Adjuvant therapy with 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) in high-risk patients with rhegmatogenous retinal detachment (RRD) does not help prevent the development of proliferative vitreoretinopathy, as shown in a study.

A total of 325 high-risk RRD patients across 13 German trial sites were randomized to receive verum (5-FU 200 mg/ml and dalteparin 5 IU/ml; n=163) or placebo (balanced saline solution; n=162). Treatment was intravitreally administered during routine pars plana vitrectomy.

The primary endpoint was incident proliferative vitreoretinopathy grade CP (full-thickness retinal folds or subretinal strands in clock hours located posterior to equator) 1 or higher within 12 weeks after surgery. Researchers assessed the risk of this complication with the use of laser flare photometry. Fundus photographs were graded by an endpoint committee.

The mean laser flare in study eyes was 31 pc/ms. In the modified intention-to-treat population, the incidence of proliferative vitreoretinopathy did not significantly differ between the verum and placebo groups (28 percent vs 23 percent, respectively [including not assessable cases as failure]; odds ratio (OR), 1.25, 95 percent confidence interval [CI], 0.76‒2.08; p=0.77).

Results were similar in the per-protocol population, wherein the incidence was not significantly different between verum and placebo (12 percent vs 12 percent; OR, 1.05, 95 percent CI, 0.47–2.33; p=0.47).

None of the secondary endpoints (best-corrected visual acuity and redetachment rate) showed any significant difference between the two treatment groups. Additionally, there were no relevant safety risks identified.