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

Centre Hospitalier Universitaire de Nice

Status and phase: Completed; Phase 3

Conditions: Ocular Melanoma

Treatments: Drug: Aflibercept Injection; Drug: False injection

Study type: Interventional

Funder types: Other

Identifiers

NCT03172299

15-API-01

Details and patient eligibility

About

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.

Enrollment: 57 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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57 participants in 2 patient groups, including a placebo group

Injection of anti-VEGF

Active Comparator group

Treatment:

Drug: Aflibercept Injection

false injection of anti-VEGF

Placebo Comparator group

Treatment:

Drug: False injection