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

Sponsor
Centre Hospitalier Universitaire de Nice
Study ID
NCT03172299
Phase
PHASE3
Status
Completed

Conditions

  • Ocular Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept Injection — DRUG
    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.
  • False injection — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 8, 2017
Status verified
Mar 2025
Primary completion
Jan 31, 2025
Completion
Jan 31, 2025

Study Design

Enrollment
57 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Injection of anti-VEGF
  • Placebo Comparator: false injection of anti-VEGF

Primary Outcome Measure

Occurrence of neovascular glaucoma [ Time Frame: at 5 years ]

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