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)

Not Applicable

Recruiting

• Conditions: Age Related Macular Degeneration
• Interventions: Other: radiopharmaceutical

• Registration Number: NCT04005443
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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).

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-28
• Study First Posted: 2019-07-02
• Study Start: 2022-10-02
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-08
• Primary Completion: 2024-06-02
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PET at 68Ga-NODAGA-RGD	radiopharmaceutical	The first PET scan will be performed within a maximum of one month following the initial ophthalmologic assessment including OCT and measurement of visual acuity (M0);

Primary Outcome Measures

Name	Time	Method
Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal	7 months	Images from the 68Ga-NODAGA-RGD PET scan will be interpreted without results of other examinations and clinical history. Two experienced nuclear physicians unfamiliar with the results of the initial balance sheet examinations will complete a grid listing the quantification of the 68Ga-NODAGA-RGD (SUVmax) signal measured in each eye of each patient.; The signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal at M0 and M4 will be compared by a comparison test of paired averages.

Trial Locations

Locations (1)

APHM; 🇫🇷 Marseille, France