Overview
Sponsor-declared trial summary
Age-related macular degeneration
Evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in 20 patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the induction phase (after 3 months of treatment).
Key facts
- Sponsor
- Centre Hospitalier Regional De Marseille
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Eye Diseases [C11]
- Trial duration
- 2 Oct 2022 → 4 Jan 2025
- Decision date (initial)
- 2024-10-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516970-31-00
- EudraCT number
- 2019-000946-37
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
Evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in 20 patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the induction phase (after 3 months of treatment).
Secondary objectives 2
- To measure the relationship between 68Ga-NODAGA-RGD PET signal intensity (SUVmax) and retinal thickness measured by OCT, for each eye, before treatment and after the 6th intraocular injection of antiangiogenic agent.
- To measure the relationship between 68Ga-NODAGA-RGD PET signal intensity (SUVmax) and each of the psychometric scales for measuring visual acuity (ETDRS scale and Parinaud scale), for each eye, before treatment and after the 6th intraocular injection of antiangiogenic agent.
Conditions and MedDRA coding
Age-related macular degeneration
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Age ≥ 18 years
- signed informed consent
- Patient with unilateral AMD, with at least 1 focus of choroidal neovascularization on OCT, naïve to any antiangiogenic treatment.
- Initial check-up including at least OCT and visual acuity measurement, maximum 1 month old at the time of the 68Ga-NODAGA-RGD PET scan
- affiliation to a social security scheme.
Exclusion criteria 7
- pregnant or breast-feeding women
- Age ≤ 18 years
- Patients with bilateral AMD
- Patients with AMD with no neovascularization focus as assessed by the standard diagnostic battery
- Patients previously treated with antiangiogenic therapy.
- Patients suffering from any other ophthalmological pathology
- Monophtalmic patients
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The PET signal intensity ratios (SUVmax) of the AMD and contralateral eyes at M0 and M4 will be compared by a paired means comparison test.
Secondary endpoints 2
- The relationships between PET signal intensity (SUVmax) and retinal thickness measured by OCT, for each eye, will be documented at M0 and M4 respectively by a correlation study.
- The links between PET signal intensity (SUVmax) and the visual acuity score measured with each of the psychometric scales (ETDRS and Parinaud), for each eye, will be documented at M0 and M4 respectively by a correlation study.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD11418259 · Product
- Active substance
- 5-4-2S5S11S14R-14-BENZYL-11-CARBOXYMETHYL-5-3-DIAMINOMETHYLIDENEAMINOPROPYL-3691215-PENTAOXO-1471013-PENTAZACYCLOPENTADEC-2-YLBUTYLAMINO-2-47-BISCARBOXYMETHYL-147-TRIAZONAN-1-YL-5-OXOPENTANOIC Acid Radioallebled with GALLIUM-68
- Substance synonyms
- 68GA-NODAGA-RGD
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2.5 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 2.5 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- APHM
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional De Marseille
- Sponsor organisation
- Centre Hospitalier Regional De Marseille
- Address
- 80 Rue Brochier
- City
- Marseille
- Postcode
- 13005
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Philippe GARRIGUE
Public contact point
- Organisation
- Centre Hospitalier Regional De Marseille
- Contact name
- Clement PIERRE
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ended | 20 | 1 |
| 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 | 2022-10-02 | 2025-01-04 | 2022-10-02 | 2024-06-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 2019-000946-37_Protocole_DMLA-RGD | 2 |
| Recruitment arrangements (for publication) | 2019-000946-37_RECRUITEMENT ARRANGEMENT_DMLA-RGD | 1 |
| Subject information and informed consent form (for publication) | 2019-000946-37_Notice d information-consentement_V2_16112020 | 2 |
| Synopsis of the protocol (for publication) | 2019-000946-37_resume_DMLA-RGD | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-27 | France | Acceptable 2024-10-07
|
2024-10-17 |