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NCT03172299 Clinical Trial

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

Ocular Melanoma Clinical Trial

— PROTECT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03172299
Other study ID # 15-API-01
Secondary ID
Status Recruiting
Phase Phase 3
First received
Last updated
Start date June 8, 2017
Est. completion date December 2026

Study information
Verified date June 2023
Source Centre Hospitalier Universitaire de Nice
Contact Stéphanie BAILLIF, Pr
Phone 492038025
Email baillif.s@chu-nice.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 56
Est. completion date December 2026
Est. primary completion date June 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• 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.
• 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.

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of neovascular glaucoma Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp) at 5 years
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