Stargardt’s disease – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Fri, 12 Jun 2026 11:24:32 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Stargardt’s disease – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A study to evaluate the safety and effectiveness of AAVB-039 in patients with Stargardt disease https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-aavb-039-in-patients-with-stargardt-disease/ Wed, 29 Apr 2026 15:09:54 +0000 https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-effectiveness-of-aavb-039-in-patients-with-stargardt-disease/ This study focuses on Stargardt Disease, a rare condition that affects the retina, which is the light-sensitive tissue at the back of the eye. This disease often leads to a gradual loss of central vision. The research involves testing a treatment called AAVB-039, which is an experimental solution for injection delivered via subretinal administration, a method where the medicine is placed directly under the retina.

The purpose of the study is to evaluate the safety and effectiveness of AAVB-039. The investigation is divided into two parts. The first part focuses on finding the safest and most appropriate amount of the medicine to use. The second part examines how well the treatment works at that specific dose over time.

Participants in the study will be monitored to observe any changes in their vision and the health of their eyes. This includes checking the ellipsoid zone, which is a specific layer of cells in the retina that is important for clear vision, and the macula, the part of the eye responsible for detailed central sight. The study will track these changes over several years to understand the long-term impact of the treatment.

]]> A study to evaluate the safety and tolerability of tinlarebant in patients with Stargardt disease https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-how-well-patients-with-stargardt-disease-tolerate-tinlarebant-over-three-years/ Wed, 29 Apr 2026 15:09:51 +0000 https://clinicaltrials.eu/trial/a-study-to-evaluate-the-safety-and-how-well-patients-with-stargardt-disease-tolerate-tinlarebant-over-three-years/ This study focuses on Stargardt Disease, which is a rare genetic condition that causes progressive loss of vision. The research aims to evaluate the long-term safety and how well the body tolerates a medication called tinlarebant, also known as LBS-008. This medication is administered as an oral tablet.

Participants in this long-term study will take the medication over a period of three years. During this time, the effects of the treatment on the body and the eyes will be monitored to ensure it is safe for continued use.

]]> Evaluation of SB-007 Safety and Efficacy in Patients with Stargardt Disease Type 1 (STGD1) Caused by ABCA4 Gene Mutations https://clinicaltrials.eu/trial/evaluation-of-sb-007-safety-and-efficacy-in-patients-with-stargardt-disease-type-1-stgd1-caused-by-abca4-gene-mutations/ Wed, 29 Apr 2026 15:06:13 +0000 https://clinicaltrials.eu/trial/evaluation-of-sb-007-safety-and-efficacy-in-patients-with-stargardt-disease-type-1-stgd1-caused-by-abca4-gene-mutations/ This clinical trial is investigating a treatment for Stargardt Disease type 1 (STGD1), a genetic eye disorder caused by mutations in the ABCA4 gene. Stargardt disease typically leads to progressive vision loss due to the degeneration of cells in the central part of the retina. The study will test a medication called SB-007, which is administered through a subretinal injection (an injection under the retina of the eye). The purpose of this study is to evaluate whether SB-007 is safe, well-tolerated, and potentially effective for people with genetically confirmed Stargardt disease.

The study is designed as a combined Phase 1/2 trial, which means it will first determine if the treatment is safe at different dose levels, and then assess whether it shows signs of effectiveness. Participants will receive either the SB-007 treatment in one eye or serve as a control group. Throughout the study, researchers will monitor participants’ eye health using various imaging techniques such as fundus autofluorescence (FAF) and optical coherence tomography (OCT), which provide detailed pictures of the retina. They will also assess changes in vision using different vision tests that measure visual acuity and contrast sensitivity.

The study will follow participants for 96 weeks (about 2 years) after treatment to determine the long-term safety and potential benefits of SB-007. During this time, participants will attend regular check-ups where doctors will examine their eyes and assess any changes in their vision and the progression of the disease. The trial specifically targets adults between 18 and 65 years of age who have genetically confirmed Stargardt disease with mutations in both copies of the ABCA4 gene.

]]> Study on the Long-Term Safety of SAR422459 for Patients with Stargardt’s Disease https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-sar422459-for-patients-with-stargardts-disease/ Wed, 29 Apr 2026 15:00:43 +0000 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-sar422459-for-patients-with-stargardts-disease/ This clinical trial is focused on studying the long-term safety and effects of a treatment called SAR422459 in patients with Stargardt’s macular degeneration. Stargardt’s macular degeneration is a genetic eye disease that affects the retina, leading to vision loss. The treatment involves a special type of injection known as a lentiviral vector containing the human ABCA4 gene, which is designed to help address the genetic cause of the disease.

The purpose of this study is to evaluate how well patients tolerate the treatment over a long period and to observe any biological changes that occur. Participants in the study will receive the treatment as a suspension for injection. The study will monitor the occurrence of any side effects and assess any changes in eye health and the progression of retinal degeneration.

This study is open-label, meaning that both the researchers and participants know what treatment is being administered. The trial will follow patients who have previously participated in a related study and received the treatment. The study aims to gather valuable information on the treatment’s safety and its potential to slow down the progression of Stargardt’s macular degeneration.

]]> Study on Tinlarebant for Treating Stargardt Disease in Adolescents https://clinicaltrials.eu/trial/study-on-tinlarebant-for-treating-stargardt-disease-in-adolescents/ Wed, 29 Apr 2026 14:29:23 +0000 https://clinicaltrials.eu/trial/study-on-tinlarebant-for-treating-stargardt-disease-in-adolescents/ This clinical trial is focused on studying Stargardt Disease, a genetic eye disorder that affects vision, particularly in adolescents. The study is testing a treatment called Tinlarebant, also known by its code name LBS-008. This medication is taken in the form of a tablet. The purpose of the study is to evaluate how effective Tinlarebant is in slowing down the progression of vision loss in young people with Stargardt Disease.

Participants in the study will be randomly assigned to receive either Tinlarebant or a placebo. The study is designed to be “double-masked,” meaning neither the participants nor the researchers will know who is receiving the actual medication and who is receiving the placebo. This helps ensure that the results are unbiased. The study will take place over a period of time, during which participants will have regular check-ups to monitor their eye health and any changes in their vision.

The main goal of the study is to see if Tinlarebant can slow the growth of areas in the eye that are losing function, known as atrophic lesions. These areas are monitored using a special type of eye photography called FAF (fundus autofluorescence). Additionally, the study will look at changes in the thickness and structure of the retina, the part of the eye that is crucial for vision, using a method called SDOCT (spectral-domain optical coherence tomography). The study aims to provide valuable information on the safety and effectiveness of Tinlarebant for treating Stargardt Disease in adolescents.

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