NCT03172299

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nice · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ocular Melanoma

Interventions

Type	Name	Description
DRUG	Aflibercept Injection	Intravitreal injection of aflibercept 40mg/mL will be done on patients. The injections will be performed on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, injections will be performed every 3 months for a period of 21 months.
DRUG	False injection	A false injection will be done on patients on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, falses injections will be performed every 3 months for a period of 21 months.

Timeline

• Start date: 2017-06-08
• Primary completion: 2025-01-31
• Completion: 2025-01-31
• First posted: 2017-06-01
• Last updated: 2025-03-24

Locations

1 site across 1 country: France