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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)

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ClinicalTrials.gov Identifier: NCT04005443
Recruitment Status : Not yet recruiting
First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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).

Condition or disease Intervention/treatment Phase
Age Related Macular Degeneration Other: radiopharmaceutical Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Diagnostic
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)
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : July 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal [ Time Frame: 7 months ]

    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.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005443


Contacts
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Contact: Philippe Garrigue philippe.garrigue@univ-amu.fr
Contact: DRS AP-HM drci@ap-hm.fr

Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD Assistance Publique-Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT04005443    
Other Study ID Numbers: 2019-06
2019-000946-37 ( EudraCT Number )
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action