BS01 Gene Therapy for Geographic Atrophy in Dry AMD Patients
BS01
+ Sham procedure control
Eye Diseases+2
+ Macular Degeneration
+ Retinal Degeneration
Treatment Study
Summary
Study start date: January 8, 2026
Actual date on which the first participant was enrolled.This study aims to explore the safety and effectiveness of a new treatment called BS01 for patients with a condition known as geographic atrophy (GA), which is linked to dry age-related macular degeneration (AMD). Dry AMD is a common eye disease that can cause vision loss in older adults, and GA is an advanced form of this condition. The study is important because there are currently limited treatment options available for this type of vision loss. By testing this new approach, researchers hope to find a way to slow down or improve the condition, offering hope for better management of GA. Participants in this study receive an injection of the treatment directly into the eye, known as an intravitreal injection. The study is carried out in two parts: the first part tests different doses to find the most appropriate one, while the second part focuses on expanding the study to more patients using the selected dose. Some participants will receive a sham injection, which means they undergo a procedure without the active treatment, to help compare results. Researchers will assess the safety of the treatment and its ability to improve or stabilize vision, providing valuable information on potential risks and benefits.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 50 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.3 intervention groups are designated in this study
33.333% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalGroup III
ShamStudy Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location