Overview

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

Status:
Not yet recruiting
Trial end date:
2024-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Treatments:
Aflibercept
Bevacizumab
Endothelial Growth Factors
Criteria
Inclusion Criteria:

- Age ≥ 18 years

- Choroid melanoma more than 7mm thick and / or over basal diameter of 15mm treated by
proton therapy

Exclusion Criteria:

- Iris melanoma

- Melanoma immediately metastatic

- Pregnant or breastfeeding women

- Known hypersensitivity to aflibercept (anti-VEGF selected)