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

NCT03172299 | Completed Phase 3 DMC

• 1 other identifier: 15-API-01
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Ocular Melanoma

Outcome Measures

Primary Outcomes (1)

• Occurrence of neovascular glaucoma

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

  at 5 years

Study Arms (2)

Injection of anti-VEGF

ACTIVE COMPARATOR

Drug: Aflibercept Injection

false injection of anti-VEGF

PLACEBO COMPARATOR

Drug: False injection

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.

Injection of anti-VEGF

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.

false injection of anti-VEGF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Choroid melanoma more than 7mm thick and / or over basal diameter of 15mm treated by proton therapy

You may not qualify if:

• Iris melanoma
• Melanoma immediately metastatic
• Pregnant or breastfeeding women
• Known hypersensitivity to aflibercept (anti-VEGF selected)

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice

Nice, 06003, France

Location

MeSH Terms

Conditions

Uveal Melanoma

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Melanoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Uveal Neoplasms; Eye Neoplasms; Neoplasms by Site; Eye Diseases; Uveal Diseases

Study Officials

• Stéphanie BAILLIF, Pr

  Centre Hospitalier Universitaire de Nice

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2017
• First Posted: June 1, 2017
• Study Start: June 8, 2017
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)