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)

Age Related Macular Degeneration Clinical Trial

— DMLA-RGD  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04005443
• Other study ID #: 2019-06
• Secondary ID: 2019-000946-37
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2022
• Est. completion date: December 30, 2024

Study information

• Verified date: February 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Philippe Garrigue
• Phone: +33671701443
• Email: philippe.garrigue[@]univ-amu.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: June 2, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	APHM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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