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)

NCT04005443 | Unknown

• 2 other identifiers: 2019-062019-000946-37
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

PET at 68Ga-NODAGA-RGD

OTHER

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

Interventions

radiopharmaceutical OTHER

his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score

PET at 68Ga-NODAGA-RGD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

APHM

Marseille, 13015, France

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Radiopharmaceuticals

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Molecular Mechanisms of Pharmacological Action; Indicators and Reagents; Laboratory Chemicals; Specialty Uses of Chemicals

Study Officials

• Emilie Garrido Pradalie

  Assistance Publique-Hôpitaux de Marseille

  STUDY DIRECTOR

Central Study Contacts

Philippe Garrigue

CONTACT

+33671701443; philippe.garrigue@univ-amu.fr

DRS AP-HM

CONTACT

+33491381245; promotion.interne@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In this study, two 68Ga-NODAGA-RGD PET scans will be performed for each patient included : * The first PET will be carried out within a maximum of one month following the assessment initial ophthalmologic including OCT and measurement of visual acuity (M0); * The second PET scan will be performed at the same time as the ophthalmic assessment including OCT and measurement of visual acuity (at M4), before the 5th intraocular injection antiangiogenic.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: July 2, 2019
• Study Start: October 2, 2022
• Primary Completion: June 2, 2024
• Study Completion: December 30, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

FR (1)