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

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on studying age-related macular degeneration (AMD), a common eye condition that can lead to vision loss in older adults. The study will use a special imaging technique called 68Ga-NODAGA-RGD PET imaging to observe changes in the eyes of patients with AMD. This imaging method involves a solution for injection that helps visualize certain activities in the eye related to the disease.

The purpose of the study is to evaluate how well this imaging technique can show the effects of treatment in patients with AMD. Participants will receive intraocular antiangiogenic injections, which are treatments that help reduce abnormal blood vessel growth in the eye. The study will observe the patients over a period of three months to see how their eyes respond to the treatment.

Throughout the study, the imaging technique will be used to compare the affected eye with the unaffected eye. This will help researchers understand the relationship between the imaging results and changes in the eye's structure and vision. The study aims to provide valuable insights into the effectiveness of the treatment and the potential of the imaging method in monitoring AMD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on criteria such as age, medical condition, and previous treatments.
A comprehensive check-up is conducted, including an eye examination with optical coherence tomography (OCT) and a visual acuity test. These tests should be no older than one month at the time of the 68Ga-NODAGA-RGD PET scan.
Step 2
PET scan
A 68Ga-NODAGA-RGD PET scan is performed to assess the molecular activity in the eyes. This scan helps in evaluating the response to treatment.
The scan involves an injection of a solution called 68Ga-RGD 15MBq/mL prep through an intravenous route. This is a solution for injection that helps in imaging the eye.
Step 3
Treatment phase
The treatment phase lasts for three months. During this time, regular intraocular antiangiogenic injections are administered to manage the condition.
These injections aim to reduce abnormal blood vessel growth in the eye, which is a characteristic of age-related macular degeneration (AMD).
Step 4
Follow-up PET scan
At the end of the three-month treatment phase, a follow-up 68Ga-NODAGA-RGD PET scan is conducted.
This scan is used to compare the molecular activity in the eyes before and after the treatment, helping to evaluate the effectiveness of the therapy.
Step 5
Final assessment
A final assessment is performed to analyze the results of the PET scans and other tests conducted during the trial.
The intensity of the PET signal and its relationship with retinal thickness and visual acuity are documented and analyzed.

Who can join the trial?

6 criteria

Age must be 18 years or older.
You must provide a signed informed consent, which means you agree to participate after understanding the study details.
You should have unilateral AMD (age-related macular degeneration in one eye) with at least one area of abnormal blood vessel growth in the eye, as seen on an OCT scan. OCT stands for Optical Coherence Tomography, a type of eye scan.
You must not have received any antiangiogenic treatment before. Antiangiogenic treatments are used to stop the growth of new blood vessels in the eye.
You need to have an initial check-up that includes an OCT scan and a visual acuity test (a test to measure how well you see). This check-up should be done within one month before the special PET scan used in the study.
You must be affiliated with a social security scheme, meaning you have some form of health insurance or social security coverage.

Who cannot join the trial?

7 criteria

Patients who have any other eye diseases besides **age-related macular degeneration**.
Patients who have had any eye surgery in the last 3 months.
Patients who are currently participating in another clinical trial.
Patients who have a known allergy to the substances used in the study.
Patients who are pregnant or breastfeeding.
Patients who have a serious illness that could interfere with the study.
Patients who are unable to follow the study procedures or attend the required visits.

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Verified
Assistance Publique Hopitaux De Marseille
Marseille, France

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Investigated drugs

68Ga-NODAGA-RGD is a special imaging agent used in this clinical trial. It helps doctors see the activity of blood vessels in the eye using a type of scan called PET imaging. This is important for patients with a condition called AMD, which affects the eyes. The imaging agent helps to show how well the treatment is working by highlighting changes in the blood vessels after the patient receives treatment.

Intraocular antiangiogenic injections are treatments given directly into the eye to help stop the growth of abnormal blood vessels. These injections are used for patients with AMD to prevent further damage to the eye and to maintain vision. The trial aims to see how effective these injections are by using the special imaging agent to track changes in the eye's blood vessels over time.

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

What is already known about the treatment

68Ga-NODAGA-RGD – This medication is administered through a PET imaging scan, which is a type of medical imaging technique. It is currently being studied in clinical trials to assess its effectiveness in monitoring treatment response in patients with age-related macular degeneration (AMD). The main therapeutic indication is to evaluate the molecular response to antiangiogenic treatments in the eye. At the molecular level, it works by binding to specific proteins involved in the formation of new blood vessels, allowing doctors to visualize and assess the activity of these processes. It is classified as a radiopharmaceutical used for diagnostic imaging.

Investigated diseases

Age-related macular degeneration – Age-related macular degeneration is a condition that affects the central part of the retina, known as the macula, leading to vision loss. It typically progresses with age and is characterized by the deterioration of the macula, which is responsible for sharp, central vision. The disease can manifest in two forms: dry and wet. The dry form involves the thinning of the macula and the accumulation of drusen, small yellow deposits. The wet form is marked by abnormal blood vessel growth under the retina, which can leak fluid or blood. Over time, this can cause damage to the macula, leading to blurred or reduced central vision.