Overview
Sponsor-declared trial summary
Patient with large choroid melanoma 7 mm thick and/or more than 15 mm of basal diameter treated by proton therapy
Compare neovascular glaucoma rate 5 years after proton therapy, in patients large with choroid melanoma, between a group of patients treated preventively by intravitreal anti-VEGF versus a second group of patients receiving a false injection.
Key facts
- Sponsor
- Centre Hospitalier Universitaire De Nice
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 8 Jun 2017 → 31 Jan 2025
- Decision date (initial)
- 2024-10-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513746-11-00
- EudraCT number
- 2016-003329-40
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Compare neovascular glaucoma rate 5 years after proton therapy, in patients large with choroid melanoma, between a group of patients treated preventively by intravitreal anti-VEGF versus a second group of patients receiving a false injection.
Conditions and MedDRA coding
Patient with large choroid melanoma 7 mm thick and/or more than 15 mm of basal diameter treated by proton therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10008773 | Choroid melanoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Age ≥ 18 years
- Choroid melanoma more than 7 mm thick and / or over basal diameter of 15mm treated by proton therapy
Exclusion criteria 4
- Iris melanoma
- Melanoma immediately metastatic
- Pregnant or breastfeeding women
- Known hypersensitivity to aflibercept (anti-VEGF selected)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence of neovascular glaucoma after radiation-induced proton therapy. Clinical diagnosis (examination at the slit lamp)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Eylea 40 mg/mL solution for injection in pre-filled syringe
PRD3117102 · Product
- Active substance
- Aflibercept
- Substance synonyms
- BAY 86-5321, ABP 938, AVE0005, BAY86-5321, VEGF TRAP, BAY 86-5319
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTION
- Max daily dose
- 0 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 23 Month(s)
- Authorisation status
- Authorised
- ATC code
- S01LA05 — -
- Marketing authorisation
- EU/1/12/797/001
- MA holder
- BAYER AG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Universitaire De Nice
- Sponsor organisation
- Centre Hospitalier Universitaire De Nice
- Address
- 4 Avenue Reine Victoria
- City
- Nice
- Postcode
- 06000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Pr BAILLIF
Public contact point
- Organisation
- Centre Hospitalier Universitaire De Nice
- Contact name
- Christine PINTARIC
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 56 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2017-06-08 | 2025-01-31 | 2017-06-08 | 2020-06-29 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Etude PROTECT_Résumé du rapport final SUM-114973
|
2026-01-15T16:31:35 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Résumé des résultats de l'essai clinique à destination du grand public | 2026-01-15T16:31:40 | Submitted | Laypersons Summary of Results |
Documents 6 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | 15API01_RRF_public_15012026 | 1 |
| Protocol (for publication) | D1_Protocole 2024-513746-11-00 | 10 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_NA | 0.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF descritpion | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Eylea | 1 |
| Summary of results (for publication) | 15API01_RRF_15012026 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-11 | France | Acceptable 2024-09-29
|
2024-10-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-11-15 | France | Acceptable | 2024-12-19 |