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5-[4-[(2S,5S,11S,14R)-14-Benzyl-11-(Carboxymethyl)-5-[3-(Diaminomethylideneamino)Propyl]-3,6,9,12,15-Pentaoxo-1,4,7,10,13-Pentazacyclopentadec-2-Yl]Butylamino]-2-[4,7-Bis(Carboxymethyl)-1,4,7-Triazonan-1-Yl]-5-Oxopentanoic Acid Radioallebled With Gallium-68

This article discusses a clinical trial investigating the use of a specialized imaging technique called 68Ga-NODAGA-RGD PET to monitor treatment responses in patients with Age-related Macular Degeneration (AMD). The study aims to evaluate how this advanced imaging method can help assess the effectiveness of antiangiogenic injections in patients with unilateral AMD, potentially improving treatment monitoring and patient outcomes.

Table of Contents

Introduction to 68Ga-NODAGA-RGD

68Ga-NODAGA-RGD is a novel imaging agent being studied for its potential use in patients with Age-related Macular Degeneration (AMD). This compound, also known by its chemical name 5-[4-[(2S,5S,11S,14R)-14-BENZYL-11-(CARBOXYMETHYL)-5-[3-(DIAMINOMETHYLIDENEAMINO)PROPYL]-3,6,9,12,15-PENTAOXO-1,4,7,10,13-PENTAZACYCLOPENTADEC-2-YL]BUTYLAMINO]-2-[4,7-BIS(CARBOXYMETHYL)-1,4,7-TRIAZONAN-1-YL]-5-OXOPENTANOIC ACID RADIOALLEBLED WITH GALLIUM-68, is a radioactive tracer used in Positron Emission Tomography (PET) imaging[1]. It’s important to note that this is not a treatment for AMD, but rather a diagnostic tool to help monitor the disease and its response to treatment.

Purpose and Use in AMD

The primary purpose of 68Ga-NODAGA-RGD is to help doctors visualize and measure angiogenic activity in the eyes of patients with AMD. Angiogenesis refers to the formation of new blood vessels, which is a key feature of AMD. By using this imaging agent, doctors hope to:

  • Detect and measure the extent of abnormal blood vessel growth in the eye
  • Monitor how well anti-angiogenic treatments (medications that prevent new blood vessel formation) are working
  • Potentially predict treatment outcomes and guide personalized treatment plans
This innovative approach could provide valuable insights into the progression of AMD and the effectiveness of current treatments[1].

Current Clinical Trial

A Phase 2 clinical trial is currently underway to evaluate the effectiveness of 68Ga-NODAGA-RGD PET imaging in patients with AMD. The main objective of this trial is to assess whether this imaging technique can demonstrate a molecular therapeutic response to intraocular anti-angiogenic injections after three months of treatment in 20 patients with unilateral AMD[1].

Secondary objectives of the trial include:

  • Measuring the relationship between the 68Ga-NODAGA-RGD PET signal intensity and retinal thickness (measured by Optical Coherence Tomography or OCT)
  • Evaluating the correlation between the PET signal intensity and visual acuity scores (measured using standard eye charts like the ETDRS and Parinaud scales)
These measurements will be taken before treatment and after the 6th intraocular injection of the anti-angiogenic agent[1].

How the Drug is Administered

68Ga-NODAGA-RGD is administered as a solution for injection. It is given intravenously (through a vein) at a maximum dose of 2.5 MBq/kg (megabecquerels per kilogram of body weight). The treatment period is typically short, lasting up to 2 days[1]. This brief exposure is designed to minimize radiation exposure while still providing valuable diagnostic information.

Who Can Participate in the Trial

The clinical trial has specific criteria for who can participate. Eligible participants include:

  • Patients with unilateral AMD (affecting only one eye)
  • Those with at least one focus of choroidal neovascularization (new blood vessel growth) on OCT
  • Patients who have not received any previous anti-angiogenic treatment
  • Individuals who have had a recent initial check-up including OCT and visual acuity measurement
Exclusion criteria include:
  • Pregnant or breastfeeding women
  • Patients with bilateral AMD (affecting both eyes)
  • Those with other eye conditions
  • Patients who have already received anti-angiogenic therapy
These criteria ensure that the study focuses on a specific group of AMD patients who are most likely to benefit from this new imaging technique[1].

Potential Benefits and Outcomes

While it’s important to note that 68Ga-NODAGA-RGD is still in the research phase, the potential benefits of this imaging technique could be significant for AMD patients. If successful, it could:

  • Provide a more accurate way to assess the progression of AMD
  • Help doctors determine how well treatments are working
  • Allow for more personalized treatment plans based on each patient’s specific disease activity
  • Potentially lead to earlier intervention and better outcomes for AMD patients
The results of this clinical trial will help determine whether 68Ga-NODAGA-RGD PET imaging could become a valuable tool in the management of AMD in the future[1].

Aspect Details
Study Type Phase 2 clinical trial
Condition Unilateral Age-related Macular Degeneration (AMD)
Main Objective Evaluate 68Ga-NODAGA-RGD PET imaging for monitoring antiangiogenic treatment response
Imaging Agent 68Ga-NODAGA-RGD (68Ga-RGD 15MBq/mL prep)
Administration Route Intravenous injection
Dosage Maximum 2.5 MBq/kg
Treatment Duration 4 months (measurements at M0 and M4)
Secondary Measurements Retinal thickness (OCT), Visual acuity (ETDRS and Parinaud scales)
Number of Participants 20 patients with unilateral AMD

FAQ

  • What is the main purpose of this clinical trial? The main purpose of this clinical trial is to evaluate the ability of 68Ga-NODAGA-RGD PET imaging to demonstrate a molecular therapeutic response to intraocular antiangiogenic injections in patients with unilateral Age-related Macular Degeneration (AMD) after 3 months of treatment.
  • Who can participate in this study? Participants must have unilateral AMD with at least one focus of choroidal neovascularization on OCT, be new to antiangiogenic treatment, have signed informed consent, and be affiliated with a social security scheme. Patients with bilateral AMD, previous antiangiogenic therapy, or other ophthalmological conditions are excluded.
  • What does the imaging procedure involve? The imaging procedure involves a 68Ga-NODAGA-RGD PET scan, which uses a special radioactive tracer to visualize angiogenic activity in the eye. This non-invasive imaging technique helps researchers assess the effectiveness of antiangiogenic treatments for AMD.
  • How long does the study last for each participant? The study involves measurements at the beginning (M0) and after 4 months (M4) of treatment. Participants will receive intraocular antiangiogenic injections during this period, with imaging and other assessments performed at these two time points.
  • What other measurements will be taken during the study? In addition to the PET imaging, the study will measure retinal thickness using OCT (Optical Coherence Tomography) and assess visual acuity using psychometric scales (ETDRS and Parinaud scales). These measurements will be taken before treatment and after the 6th intraocular injection of the antiangiogenic agent.

Ongoing Clinical Trials on 5-[4-[(2S,5S,11S,14R)-14-Benzyl-11-(Carboxymethyl)-5-[3-(Diaminomethylideneamino)Propyl]-3,6,9,12,15-Pentaoxo-1,4,7,10,13-Pentazacyclopentadec-2-Yl]Butylamino]-2-[4,7-Bis(Carboxymethyl)-1,4,7-Triazonan-1-Yl]-5-Oxopentanoic Acid Radioallebled With Gallium-68

  • Study on the Use of 68Ga-NODAGA-RGD for Monitoring Treatment in Patients with Age-Related Macular Degeneration

    Not recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    France

Glossary

  • Age-related Macular Degeneration (AMD): A common eye condition that affects the central part of the retina (macula), causing vision loss in older adults. It can be 'dry' or 'wet', with the latter involving abnormal blood vessel growth.
  • 68Ga-NODAGA-RGD PET: A specialized imaging technique using a radioactive tracer (68Ga-NODAGA-RGD) with Positron Emission Tomography (PET) to visualize and measure angiogenic activity in the eye.
  • Antiangiogenic injections: Treatments that inhibit the growth of new blood vessels, commonly used in wet AMD to slow or stop the progression of abnormal blood vessel growth in the eye.
  • Choroidal neovascularization: The growth of new, abnormal blood vessels in the choroid layer of the eye, a hallmark of wet AMD that can lead to vision loss if left untreated.
  • OCT (Optical Coherence Tomography): A non-invasive imaging technique that uses light waves to take cross-section pictures of the retina, allowing doctors to measure retinal thickness and detect abnormalities.
  • ETDRS scale: Early Treatment Diabetic Retinopathy Study scale, a standardized method for measuring visual acuity in clinical trials and practice.
  • Parinaud scale: A scale used to measure near vision acuity, named after the French ophthalmologist Henri Parinaud.
  • SUVmax: Maximum Standardized Uptake Value, a measure used in PET imaging to quantify the intensity of radiotracer uptake in a specific area.
  • Intraocular: Referring to the inside of the eye, in this context, intraocular injections are medications delivered directly into the eye.

References

  1. http://clinicaltrials.eu/trial/study-on-the-use-of-68ga-nodaga-rgd-for-monitoring-treatment-in-patients-with-age-related-macular-degeneration/