Back to resultsPrevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma (PROTECT)
Primary Purpose
Ocular Melanoma
Status
Not yet recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Aflibercept Injection
False injection
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Melanoma
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)
Sites / Locations
- CHU de Nice
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Injection of anti-VEGF
false injection of anti-VEGF
Arm Description
Outcomes
Primary Outcome Measures
Occurrence of neovascular glaucoma
Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)
Secondary Outcome Measures
Full Information
NCT ID
NCT03172299
First Posted
May 29, 2017
Last Updated
June 13, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT03172299
Brief Title
Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
December 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ocular Melanoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Injection of anti-VEGF
Arm Type
Active Comparator
Arm Title
false injection of anti-VEGF
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Aflibercept Injection
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
False injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of neovascular glaucoma
Description
Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)
Time Frame
at 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphanie BAILLIF, Pr
Phone
492038025
Ext
+33
Email
baillif.s@chu-nice.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stéphanie BAILLIF, Pr
Organizational Affiliation
Centre Hospitalier Universitaire de Nice
Official's Role
Study Director
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06003
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie BAILLIF, Pr
12. IPD Sharing Statement
Learn more about this trial
Prevention of Neovascular Glaucoma by Intravitreal Injections of Anti-VEGF in Patients Treated With Proton Therapy for a Large Choroidal Melanoma
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