Recruiting

BS01 Gene Therapy for Geographic Atrophy in Dry AMD Patients

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What is being tested

BS01

+ Sham procedure control

BiologicalOther
Who is being recruted

Eye Diseases+2

+ Macular Degeneration

+ Retinal Degeneration

From 50 to 85 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 1 & 2
Interventional
Study Start: January 2026
See protocol details

Summary

Principal SponsorBionic Sight LLC
Study ContactSheila Nirenberg, PhD+
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleA Phase 1/2 Study to Evaluate the Safety and Efficacy of Intravitreal Administration of BS01, a Recombinant Adeno-Associated Virus Vector Expressing ChronosFP (AAV2-CAGChronosFP) in Patients With Geographic Atrophy Secondary to Dry AMD 
NCT07158775
Principal SponsorBionic Sight LLC
Study ContactSheila Nirenberg, PhD+
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

40 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Eye DiseasesMacular DegenerationRetinal DegenerationRetinal DiseasesGeographic Atrophy

Criteria

11 inclusion criteria required to participate
Signed informed consent obtained before screening.

Men or women between 50 and 85 years of age inclusive at the time of signing the informed consent.

Geographic atrophy with some macula foveal involvement secondary to dry AMD.

Total GA area ≥ 5 and ≤ 17.5 mm2 (2 and 7 disk areas respectively), based on Heidelberg Region Finder or equivalent automated software.

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13 exclusion criteria prevent from participating
Previous therapeutic radiation in the region of the SE.

Previous treatment with any ocular or systemic gene transfer product.

Any treatment with an investigational agent in the past 60 days for any condition.

Women who are pregnant or nursing.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Sham

Study 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

Recruiting

NJ Retina

Edison, United StatesSee the location
Recruiting
One Study Center