drugset / Trial / NCT03172299

Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated with Proton Therapy for a Large Choroidal Melanoma

NCT03172299

Phase 3 Completed 57 enrolled Centre Hospitalier Universitaire de Nice
RandomizedParallel-groupDouble-blindTreatment

Summary

The reference treatment of ocular melanoma is a conservative treatment by proton therapy. Its goal is to treat the tumor while preserving the eyeball and visual acuity. However, ablation of the eyeball is sometimes necessary after proton therapy in the case of neovascular glaucoma. This complication occurs in 7 to 47% of cases (depending on the size of the tumor) and is associated with hypersecretion of Vascular Endothelial Growth Factor (VEGF) related to necrotic and inflammatory tumor tissue after proton therapy or ischemic retina. The intravitreal injections of anti-VEGF are used in the treatment of neovascular radicular glaucoma without avoiding enucleation in all cases. The investigators propose to study the prevention of neovascular glaucoma by intravitreal prophylactic administration of anti-VEGF.

Timeline

Start
2017-06-08
Primary completion
2025-01-31
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aflibercept Protein / enzyme biologic 40 mg/ml Intravitreal

Indications