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

Phase 3

Completed

• Conditions: Ocular Melanoma
• Interventions: Drug: Aflibercept Injection; Drug: False injection

• Registration Number: NCT03172299
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-05-29
• Study First Posted: 2017-06-01
• Study Start: 2017-06-08
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injection of anti-VEGF	Aflibercept Injection	-
false injection of anti-VEGF	False injection	-

Primary Outcome Measures

Name	Time	Method
Occurrence of neovascular glaucoma	at 5 years	Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)

Trial Locations

Locations (1)

CHU de Nice; 🇫🇷 Nice, France