Molecular Imaging Exploration of Ocular Angiogenic Activityand Evaluation of Its Interest in the Therapeutic Follow-upof Patients With AMD (Age-related Macular Degeneration)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported