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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-000946-37 | EudraCT Number |
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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PET at 68Ga-NODAGA-RGD | Other | 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); |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiopharmaceutical | Other | his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score |
| Measure | Description | Time Frame |
|---|---|---|
| Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal | 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. | 7 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe Garrigue | Contact | +33671701443 | +33 | philippe.garrigue@univ-amu.fr |
| DRS AP-HM | Contact | +33491381245 | +33 | promotion.interne@ap-hm.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emilie Garrido Pradalie | Assistance Publique-Hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHM | Recruiting | Marseille | 13015 | France |
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In this study, two 68Ga-NODAGA-RGD PET scans will be performed for each patient included :
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D019275 | Radiopharmaceuticals |
| ID | Term |
|---|---|
| D064907 | Diagnostic Uses of Chemicals |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D007202 | Indicators and Reagents |
| D019995 | Laboratory Chemicals |
| D020313 | Specialty Uses of Chemicals |
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