Study on the Safety and Use of AVT06 (Aflibercept) for Patients with Chorioretinal Vascular Diseases

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What is this study about?

This clinical trial is focused on studying the handling and safety of a treatment called Aflibercept, which is used for various eye conditions. These conditions include neovascular age-related macular degeneration (a type of vision loss in older adults), diabetic macular edema (swelling in the retina due to diabetes), myopic choroidal neovascularization (abnormal blood vessel growth in the eye due to severe nearsightedness), retinal vein occlusion (blockage of veins in the retina), and diabetic retinopathy (damage to the retina caused by diabetes). The treatment is administered as a solution for injection using a pre-filled syringe, referred to as AVT06.

The purpose of this study is to ensure that the AVT06 pre-filled syringe is handled correctly and safely, and to evaluate the safety of the treatment when injected into the eye. Participants in the study will receive the treatment through an injection into the eye, known as intravitreal use. The study will follow participants over a period to monitor the safety and effectiveness of the treatment. There is also an optional extension phase for further observation.

Throughout the study, the focus will be on the successful administration of the treatment and monitoring any side effects related to the eye. The study aims to provide valuable information on the safe use of Aflibercept in treating these eye conditions, helping to improve treatment options for patients with these diseases.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose and procedures. The patient must read, understand, and sign an informed consent form before any study-specific procedures begin.

2 initial assessment

An initial assessment will be conducted to confirm the diagnosis of chorioretinal vascular disease, which may include conditions such as neovascular age-related macular degeneration, diabetic macular edema, myopic choroidal neovascularization, retinal vein occlusion, or diabetic retinopathy.

The study eye, which is eligible for treatment with aflibercept, will be selected by the principal investigator.

3 treatment administration

The patient will receive an injection of aflibercept using a pre-filled syringe. This medication is administered through an intravitreal injection, which means it is injected into the eye.

The primary goal is to demonstrate the appropriate and safe handling of the pre-filled syringe and to evaluate the ocular safety of the medication.

4 monitoring and follow-up

The patient will be monitored for any side effects or adverse events related to the eye from the baseline to week 4.

The study will assess the proportion of successful injections and any incidence of ocular side effects.

5 optional extension phase

After the initial phase, there is an optional extension phase where the patient may continue to receive the treatment with the pre-filled syringe.

The decision to participate in this phase will be based on the patient’s condition and the investigator’s recommendation.

Who Can Join the Study?

Must be a male or female who is at least 18 years old.
Must have a diagnosis of one of the following eye conditions in the study eye:
- Neovascular age-related macular degeneration (nAMD): A condition where new blood vessels grow under the retina, causing vision loss.
- Diabetic macular edema (DME): Swelling in the part of the retina called the macula, due to diabetes.
- Retinal vein occlusion (RVO): A blockage in the veins of the retina, affecting vision.
- Diabetic retinopathy (DR): Damage to the blood vessels in the retina due to diabetes.
- Myopic choroidal neovascularization (CNV): New blood vessel growth under the retina due to severe nearsightedness.
The study eye must be suitable for treatment with aflibercept, a medication used for certain eye conditions, as determined by the study doctor.
The participant or their legal representative must be able to read, understand, and sign a consent form approved by an ethics committee before any study procedures begin.
Must be willing and able to follow all study procedures and likely to complete the study.
Must agree to follow contraception requirements:
- For males: Must use contraception during the treatment period and for at least 3 months after the last eye injection, and must not donate sperm during this time.
- For females: Must not be pregnant, breastfeeding, or planning to become pregnant during the treatment period and for at least 3 months after the last eye injection. Must not donate eggs or store them for reproduction during this time. Must meet one of the following:
  - Not a woman of childbearing potential.
  - If of childbearing potential, must agree to follow contraceptive guidance during the treatment period and for at least 3 months after the last eye injection.

Who Cannot Join the Study?

Patients with any other eye diseases that are not part of the study, such as those not related to blood vessel problems in the eye.
Patients who have had eye surgery recently or are planning to have eye surgery during the study period.
Patients who have an eye infection or inflammation at the time of the study.
Patients who are allergic to any of the study medications or their ingredients.
Patients who are participating in another clinical trial at the same time.
Patients who have a serious illness that might affect their ability to participate in the study.
Patients who are pregnant or breastfeeding.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study instructions or attend the required visits.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Pauls Stradins Clinical University Hospital	Riga	Latvia
Ngsgg Kskqeac Rncfghga Hopsgkqp	Ventspils	Latvia
Rzlv Eeec Ulbluezfcv Hspienrx	Riga	Latvia

Trial status

Country	Status	Recruitment Start
Latvia	Not recruiting	16.11.2023

Trial locations

Investigated drugs:

Aflibercept

AVT06 is a medication being studied for its use in treating chorioretinal vascular disease. The trial aims to assess how well patients can handle the pre-filled syringe (PFS) version of this medication and to ensure that it is safe for use in the eyes. The study is designed to observe any potential side effects and to confirm that the medication can be administered safely using the pre-filled syringe.

Investigated diseases:

Neovascular Age-Related Macular Degeneration (nAMD) – This is a chronic eye condition that affects the macula, the central part of the retina responsible for sharp vision. It occurs when abnormal blood vessels grow under the retina and macula, leading to leakage of blood and fluid. This leakage can cause rapid and severe vision loss if not managed. The disease typically progresses with symptoms such as blurred vision or a blind spot in the central vision. Over time, it can lead to significant visual impairment.

Diabetic Macular Edema (DME) – This condition is a complication of diabetes that affects the eyes, specifically the macula. It occurs when blood vessels in the retina leak fluid, causing the macula to swell. This swelling can lead to vision problems, including blurred or wavy vision. The progression of DME can vary, but it often results in gradual vision loss if not addressed. It is closely associated with diabetic retinopathy.

Myopic Choroidal Neovascularization (CNV) – This eye condition is associated with severe myopia, where new, abnormal blood vessels grow beneath the retina. These vessels can leak blood and fluid, leading to vision distortion and loss. The condition progresses as these vessels continue to grow and cause damage to the retina. Symptoms may include blurred vision and dark spots in the field of vision. It is a significant cause of vision impairment in people with high myopia.

Retinal Vein Occlusion (RVO) – This is a blockage of the veins carrying blood away from the retina, leading to swelling and bleeding in the eye. It can cause sudden vision loss or blurring, depending on the severity and location of the blockage. The condition progresses as the blockage persists, potentially leading to further complications like macular edema. It is often associated with other health conditions such as hypertension and diabetes.

Diabetic Retinopathy (DR) – This is a diabetes-related eye disease that affects the blood vessels in the retina. It begins with mild vision problems and can progress to more severe vision impairment. As the disease advances, blood vessels may swell and leak, or abnormal new blood vessels may grow on the retina’s surface. This progression can lead to complications such as retinal detachment or macular edema. It is a leading cause of blindness in adults with diabetes.

Trial ID:

2023-505225-13-00

Protocol code:

AVT06-GL-D01

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Safety and Use of AVT06 (Aflibercept) for Patients with Chorioretinal Vascular Diseases

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?