Clinical trial NCT04005443: Molecular Imaging Exploration of Ocular Angiogenic Activity and Evaluation of Its Interest in the Therapeutic Follow-up of Patients With AMD (Age-related Macular Degeneration)
Official title: Molecular Imaging Exploration of Ocular Angiogenic Activityand Evaluation of Its Interest in the Therapeutic Follow-upof Patients With AMD (Age-related Macular Degeneration)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Age Related Macular Degeneration
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2019-07-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In this study, two 68Ga-NODAGA-RGD PET scans will be performed for each patient included :

* The first PET will be carried out within a maximum of one month following the assessment initial ophthalmologic including OCT and measurement of visual acuity (M0);
* The second PET scan will be performed at the same time as the ophthalmic assessment including OCT and measurement of visual acuity (at M4), before the 5th intraocular injection antiangiogenic.
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Detailed description: To date, no functional imaging modality has been validated to assess the level angiogenic activity of choroidal neovascularization in AMD, while the therapeutic use of antiangiogenic agents is almost systematically in the form of intraocular injections.

The therapeutic response is observed anatomically and functionally only after 6 months of treatment. Several arguments in the literature suggest that the therapeutic response occurs earlier at the molecular level, as soon as the induction phase is complete (after 3 months of treatment). The main objective of this pilot study is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate, in patients with unilateral AMD, a molecular therapeutic response to intraocular antiangiogenic injections at the end of the first phase. induction (after 3 months of treatment).

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18, membership of a social security scheme. Signature of informed consent,
* Subject presenting AMD with unilateral involvement, involving at least 1 Choroidal neovascularization objectified in OCT, naive to any treatment antiangiogenic.
* Initial assessment including at least OCT and measurement of visual acuity, dating from maximum 1 month at the time of PET 68Ga-NODAGA-RGD.

Exclusion Criteria:

* Pregnant or breastfeeding women, as a result of radiation protection.
* Subjects under 18 years of age and / or not affiliated to a social security scheme.
* Subjects with AMD with bilateral involvement.
* Subjects with AMD without a focus of neovascularization objectified by the classic diagnostic battery.
* Subjects having already been treated with antiangiogenic therapy.
* Subjects with any other ophthalmological pathology. Monophthalmic subjects

Primary outcomes:
measure: Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: APHM
Study officials:
affiliation: Assistance Publique-Hôpitaux de Marseille
name: Emilie Garrido Pradalie
role: STUDY_DIRECTOR
References: