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)
NCT ID: NCT04005443
Last Updated: 2023-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2022-10-02
2024-12-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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NA
SINGLE_GROUP
* 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.
DIAGNOSTIC
NONE
Study Groups
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PET at 68Ga-NODAGA-RGD
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);
radiopharmaceutical
his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score
Interventions
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radiopharmaceutical
his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Assistance Publique Hopitaux De Marseille
OTHER
Responsible Party
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Principal Investigators
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Emilie Garrido Pradalie
Role: STUDY_DIRECTOR
Assistance Publique-Hôpitaux de Marseille
Locations
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APHM
Marseille, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2019-000946-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2019-06
Identifier Type: -
Identifier Source: org_study_id
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