Age Related Macular DegenerationDMLA-RGDNCT04005443
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)
A study testing radiopharmaceutical in people with Age Related Macular Degeneration, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age Related Macular Degeneration
- What is being tested?
- radiopharmaceutical
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- 2 Oct 2022to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
APHM
Marseille, 13015
Philippe Garrigue, +33 671701443 ext. +33, philippe.garrigue@ap-hm.fr
Pierre Gascon, MD, +334 91 96 49 92 ext. +33, pierre.gascon@ap-hm.fr
About this study
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)
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).
Read the 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).
- Conditions
- Age Related Macular Degeneration
- Being tested
- radiopharmaceutical
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiopharmaceuticalOther
his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score
| Study group | Role | What they receive |
|---|---|---|
| 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); Receives: Other: radiopharmaceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start2 Oct 2022
- Primary completion2 Jun 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilie Garrido Pradalie, Study director, Assistance Publique-Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005443
- Sponsor's protocol ID
- 2019-06
- Other IDs
- 2019-000946-37, 2019
- Acronym
- DMLA-RGD
- Status last verified
- Feb 2023
- First submitted
- 20 Jun 2019
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04005443
- Acronym / sponsor ID
- DMLA-RGD / 2019-06
- Conditions
- Age Related Macular Degeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 2 Oct 2022 (actual)
- Primary completion
- 2 Jun 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| PET at 68Ga-NODAGA-RGD | Other | Other: radiopharmaceuticalThe 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); |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiopharmaceuticalhis study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score | Other | PET at 68Ga-NODAGA-RGD |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilie Garrido Pradalie study director
Assistance Publique-Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radiopharmaceutical in people with Age Related Macular Degeneration, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philippe Garrigue (+33671701443 ext. +33, philippe.garrigue@univ-amu.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the signal intensity ratios of the AMD eye / contralateral eye TEP (SUVmax) signal (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.