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) (DMLA-RGD)
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|ClinicalTrials.gov Identifier: NCT04005443|
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
|Condition or disease||Intervention/treatment||Phase|
|Age Related Macular Degeneration||Other: radiopharmaceutical||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
In this study, two 68Ga-NODAGA-RGD PET scans will be performed for each patient included :
|Masking:||None (Open Label)|
|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)|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||July 30, 2021|
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);
his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score
- Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal [ Time Frame: 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005443
|Contact: Philippe Garrigueemail@example.com|
|Contact: DRS AP-HMfirstname.lastname@example.org|
|Study Director:||Jean-Olivier ARNAUD||Assistance Publique-Hôpitaux de Marseille|