The Ophthalmology Department at the University Hospital of Nice is one of two national reference centers in France for the treatment of ocular melanoma, thanks to its proton therapy facility. Beyond providing high-quality standard care, this department aims to offer patients with ocular cancer access to the latest therapeutic innovations (innovative molecules, new strategies, exploitable vulnerabilities, etc.).

The Ophthalmology Department is based at Pasteur 2 Hospital in Nice and has initiated numerous studies, including PHRC clinical trials on uveal melanoma. Here are some recently completed or ongoing studies at the University Hospital of Nice:

  • Prevention of Neovascular Glaucoma (PROTECT study): Aflibercept, an anti-angiogenic drug, was tested in a multicenter, prospective, randomized, double-blind controlled trial. Patients with large uveal melanoma are at high risk of ocular complications, including neovascular glaucoma, following proton therapy. To protect the eye and avoid enucleation, each patient received either a sham injection or the study drug via intravitreal injection, similarly to treatments for retinal neovascular diseases such as AMD. This study is now closed, with results expected in 2026 (NCT03172299).
  • SORTT Study (Study of Ophthalmic Radiation Therapy Toxicity): This is a multicenter international prospective observational study aiming to develop several grading systems for ophthalmic radiation side effects and to gather evidence on risks associated with currently used radiation techniques. This study is now closed, with results forthcoming.
  • AU-011-301 Study: This is a Phase 3 prospective randomized controlled simple-blind trial evaluating the efficacy of bel-sar administered via the suprachoroidal route in treating small choroidal melanomas located at the posterior pole (NCT06007690). This study is currently ongoing with active patient recruitment.
  • Neoadjuvant Darovasertib in Primary Uveal Melanoma: This is a Phase 3 prospective randomized controlled multi-center open-label trial of neoadjuvant darovasertib in subjects with primary non-metastatic uveal melanoma (NCT07015190). This study is currently no yet started.

The IMPT, based at the West site of Centre Antoine Lacassagne, conducts both clinical and fundamental research, relying on the MEDICYC isochronous cyclotron and the superconducting synchrocyclotron S2C2. In ocular proton therapy, the research is both clinical and physical, supported by MEDICYC.

On the clinical side, several studies are conducted in close collaboration with the Ophthalmology Department of the University Hospital of Nice. In addition to PHRC studies initiated by the ophthalmologists’ team at CHU Nice, one study analyzes the potential of new irradiation schemes spread out over time, which could possibly reduce the risk of side effects after proton therapy. A prospective database recording dosimetric and clinical data of patients treated with ocular proton therapy has been continuously maintained since June 1991. It supports the writing of scientific articles. Clinical trials are promoted to improve treatment side effects.

On the physical side, the MEDICYC ocular proton therapy machine may upgrade its beam to FLASH therapy, increasing the dose rate from 1-2 Gy/s to over 500 Gy/s, potentially a world first for ocular proton therapy. This project is currently under feasibility study. The major advantage would be, on one hand, an extremely rapid treatment, and above all, a potential reduction of toxicities, which will need to be determined through clinical, physical, and biological studies.