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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)

Primary Purpose

Age Related Macular Degeneration

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

radiopharmaceutical

About this trial

This is an interventional diagnostic trial for Age Related Macular Degeneration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

APHMRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

PET at 68Ga-NODAGA-RGD

Arm Description

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);

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT04005443

First Posted

June 20, 2019

Last Updated

February 3, 2023

Sponsor

Assistance Publique Hopitaux De Marseille

1. Study Identification

Unique Protocol Identification Number

NCT04005443

Brief Title

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)

Acronym

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)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 2, 2022 (Actual)

Primary Completion Date

June 2, 2024 (Anticipated)

Study Completion Date

December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique Hopitaux De Marseille

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age Related Macular Degeneration

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

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.

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PET at 68Ga-NODAGA-RGD

Arm Type

Other

Arm Description

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);

Intervention Type

Other

Intervention Name(s)

radiopharmaceutical

Intervention Description

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

Primary Outcome Measure Information:

Title

Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal

Description

Time Frame

7 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Philippe Garrigue

Phone

+33671701443

Ext

+33

philippe.garrigue@univ-amu.fr

First Name & Middle Initial & Last Name or Official Title & Degree

DRS AP-HM

Phone

+33491381245

Ext

+33

promotion.interne@ap-hm.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emilie Garrido Pradalie

Organizational Affiliation

Assistance Publique-Hôpitaux de Marseille

Official's Role

Study Director

Facility Information:

Facility Name

APHM

City

Marseille

ZIP/Postal Code

13015

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philippe Garrigue

Phone

+33 671701443

Ext

+33

philippe.garrigue@ap-hm.fr

First Name & Middle Initial & Last Name & Degree

Pierre Gascon, MD

Phone

+334 91 96 49 92

Ext

+33

pierre.gascon@ap-hm.fr

12. IPD Sharing Statement

Learn more about this trial

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)

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