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)

Molecular Imaging Exploration of Ocular Angiogenic Activityand Evaluation of Its Interest in the Therapeutic Follow-upof Patients With AMD (Age-related Macular Degeneration)

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 Overview

• Status: Recruiting
• Conditions: Age Related Macular Degeneration
• Intervention / Treatment: Other: radiopharmaceutical

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe Garrigue; Phone Number: +33 +33671701443; Email: philippe.garrigue@univ-amu.fr
• Study Contact Backup: Name: DRS AP-HM; Phone Number: +33 +33491381245; Email: promotion.interne@ap-hm.fr

Study Locations

• France
  • Marseille, France, 13015
    • Recruiting
    • APHM
    • Contact: Philippe Garrigue; Phone Number: +33 +33 671701443; Email: philippe.garrigue@ap-hm.fr
    • Contact: Pierre Gascon, MD; Phone Number: +33 +334 91 96 49 92; Email: pierre.gascon@ap-hm.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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);	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: Emilie Garrido Pradalie, Assistance Publique-Hôpitaux de Marseille

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 2, 2022
• Primary Completion (ANTICIPATED): June 2, 2024
• Study Completion (ANTICIPATED): December 30, 2024

Study Registration Dates

• First Submitted: June 20, 2019
• First Submitted That Met QC Criteria: June 28, 2019
• First Posted (ACTUAL): July 2, 2019

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 3, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals
• Other Study ID Numbers: 2019-06; 2019-000946-37 (EUDRACT_NUMBER)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No