Molecular imaging exploration of ocular angiogenic activity and evaluation of its relevance in the therapeutic follow-up of AMD patients.

Phase 1

• Conditions: Age-related macular degeneration; MedDRA version: 20.0Level: PTClassification code 10025409Term: Macular degenerationSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2019-000946-37-FR
• Lead Sponsor: Assistance Publique-Hôpitaux de Marseille

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-10
• Last Update Posted: 11 January 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

- Age = 18 years old, membership of a social security scheme.
- Signature of informed consent,
- Subject with unilaterally affected AMD with at least 1 focus of choroidal neovascularization objectified in OCT, naïve to any antiangiogenic treatment.
- Initial workup including at least OCT and visual acuity measurement, no more than 1 month old at the time of the 68Ga-NODAGA-RGD PET scan.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- Pregnant or breastfeeding women, as a radiation protection measure.
- Subjects under 18 years of age and/or not affiliated to a social security scheme.
- Subjects with bilateral AMD.
- Subjects presenting an AMD without neovascularization focus as determined by the classical diagnostic scheme.
- Subjects who have already been treated with antiangiogenic therapy.
- Subjects with any other ophthalmologic pathology.
- Monophthalmic subjects.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified