BS01 for Macular Degeneration

Overseen By Sheila Nirenberg, PhD+

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Bionic Sight LLC

Disqualifiers: Pregnancy, Diabetic retinopathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, BS01, for individuals with macular degeneration, specifically geographic atrophy (GA) due to dry AMD (age-related macular degeneration). The goal is to determine the optimal dose of BS01 and assess its safety and effectiveness compared to a dummy treatment (sham injection). The trial consists of two parts: initially testing different doses, followed by comparing the best dose against no treatment. Individuals with noticeable GA affecting their central vision, impacting daily life, might be suitable candidates for this trial. As a Phase 1, Phase 2 trial, this research aims to understand how BS01 works in people and measure its effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you've had any treatment with an investigational agent in the past 60 days.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that BS01 is still under investigation for safety in treating geographic atrophy (GA) caused by dry age-related macular degeneration (AMD). As an early-phase study, limited safety information is available. These studies typically aim to identify the optimal dose with minimal side effects.

Currently, specific safety data for BS01 is unavailable. However, early-phase trials generally ensure treatments are safe before advancing to larger studies, indicating that the treatment has passed some initial safety assessments.

Participants in this study will receive either a low or high dose of BS01. A sham control group, which receives a placebo treatment, is used for comparison. The study tests different doses to determine which is more tolerable.

Although detailed safety information for BS01 is not yet available, its progression through early trials suggests some initial safety promise. Prospective participants should discuss potential risks and benefits with a healthcare provider. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Unlike the standard treatments for macular degeneration, which often involve injections that aim to stop blood vessel growth in the eye, BS01 offers a potentially groundbreaking approach. Researchers are excited about BS01 because it may work by a novel mechanism that targets the underlying cellular processes causing degeneration. This could mean not only halting progression but possibly improving vision, which current options like anti-VEGF injections don't typically achieve. With both low and high-dose options being tested, researchers are eager to see how effectively these doses can enhance eye health and offer new hope for those affected by this condition.

What evidence suggests that BS01 might be an effective treatment for macular degeneration?

Research has shown that treatments for age-related macular degeneration (AMD) can improve vision. Some studies found that patients see better after treatment. In this trial, participants will receive either a low or high dose of the treatment BS01, designed to target geographic atrophy (GA), a major cause of dry AMD. Although limited data exists on BS01's effectiveness, there is hope it will match the success of other AMD treatments. Continued research is crucial to determine how well BS01 can help people with this condition. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-85 with Geographic Atrophy (GA) due to dry Age-related Macular Degeneration (AMD). Participants must have GA affecting part of the central retina, measurable lesions, and consent to the study. Those with extensive or unmeasurable GA are excluded.

Inclusion Criteria

I am between 50 and 85 years old.

I meet the basic requirements to participate in this study.

I have signed the consent form for this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-escalation

Part 1 is an open label dose-escalation study to evaluate safety and determine optimal dosing

8-12 weeks

Dose-expansion

Part 2 is a dose-expansion study with selected doses from Part 1, including a sham injection group for controlled comparison

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• BS01

Trial Overview

The study tests BS01, a new treatment given by eye injection for dry AMD-related GA. It has two parts: an initial phase where doses increase to find a safe level, followed by a larger phase comparing this dose against sham injections.

How Is the Trial Designed?

Group I: BS01 (low dose) Experimental Treatment 1 Intervention

Group II: BS01 (high dose) Experimental Treatment 1 Intervention

Group III: Sham control Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bionic Sight LLC

Lead Sponsor

Trials

1

Recruited

20+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07158775

NCT07158775 | A Phase 1/2 Study to Evaluate the Safety ...

Study Overview. This is a Phase 1/2 study, multi-center, dose-escalation interventional study of BS01 in subjects with GA secondary to dry AMD.

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12271004/

Real-World 5-Year Outcomes of Age-Related Macular ... - PMC

However, eyes with poor vision in the Dutch group demonstrated substantial improvement during the first year of treatment, with visual outcomes ...

3.

fightingblindness.org

fightingblindness.org/news/age-related-macular-degeneration-research-advances-821

Age-Related Macular Degeneration Research Advances

The primary outcome measure for the Phase 3 clinical trial was change in best-corrected visual acuity (measured by reading letters on an eye ...

4.

ophthalmologytimes.com

ophthalmologytimes.com/view/ophthalmic-innovation-by-the-decades-the-2010s

Ophthalmic innovation by the decades: The 2010s

The authors reported, “Eleven participants (79%) had improvement in at least one of four key efficacy outcomes, whereas 6 (43%) had improvement ...

5.

cgtlive.com

cgtlive.com/view/a-snapshot-of-ophthalmologic-therapies-in-development

A Snapshot of Ophthalmologic Cell and Gene Therapies in ...

Gensight Biologics' gene therapy GS010 has so far demonstrated positive data in 90 participants in the phase 3 REFLECT trial (NCT03293524), ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11039576/

Real-World Safety Outcomes with Brolucizumab in ... - PMC

In this large real-world brolucizumab safety study, 3.4% of eyes experienced an IOI, RV, and/or RO event. Among eyes that experienced an adverse ...

7.

trialx.com

trialx.com/clinical-trials/listings/327177/a-phase-12-study-4/

A Phase 1/2 Study to Evaluate the Safety and Efficacy of ...

Overview. This is a Phase 1/2 study, multi-center, dose-escalation interventional study of BS01 in subjects with GA secondary to dry AMD.

8.

patlynk.com

patlynk.com/trial/NCT07158775

BS01 Gene Therapy for Geographic Atrophy in Dry AMD Patients

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), ...

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8613703/

Safety Outcomes of Brolucizumab in Neovascular Age ... - PMC

This study reports early safety data following real-world brolucizumab treatment, building on other recent reports of the real-world safety of ...