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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)

Recruiting
18 years of age
Both
Phase N/A

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Overview

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).

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

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 details

Age Related Macular Degeneration

NCT04005443

Assistance Publique Hopitaux De Marseille

25 January 2024

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