Clinical trial

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

Name

15-API-01

Description

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.

Trial arms

Trial start

2017-06-08

Estimated PCD

2025-06-01

Trial end

2026-12-01

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Injection of anti-VEGF

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.

Arms:

false injection of anti-VEGF

Size

Primary endpoint

Occurrence of neovascular glaucoma

at 5 years

Eligibility 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)

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 56, 'type': 'ESTIMATED'}}

Updated at

2023-10-30

1 organization

2 products

1 indication

Organization

Centre Hospitalier Universitaire de Nice

Product

Aflibercept

Indication

Ocular melanoma

Product

False