STL303 for Macular Degeneration

Not yet recruiting at 59 trial locations
CO
Overseen ByClinical Operations Manager
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Sitala Bio LTD
Must be taking: Vaccinations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of a treatment called STL303, a new potential drug for people with geographic atrophy (GA) due to age-related macular degeneration (AMD). GA occurs when cells in the back of the eye die, causing blurry or missing spots in central vision. Participants will receive either one of two doses of STL303 or a placebo (inactive substance) to compare results. This trial may suit individuals diagnosed with non-exudative AMD in both eyes and experiencing blurry central vision due to GA. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to the development of a potentially effective treatment.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking systemic immunosuppressants or other immunomodulatory drugs at least 90 days before starting the study. If you're taking other medications, the protocol doesn't specify, so it's best to discuss with the study team.

Is there any evidence suggesting that STL303 is likely to be safe for humans?

Research has shown that STL303 has been studied for its safety in treating geographic atrophy, a condition where eye cells die, leading to vision loss from age-related macular degeneration. Early results from a study on STL303 were promising, with initial safety data indicating that participants tolerated the treatment well. In these studies, no major side effects were reported, meaning most people did not experience serious issues.

Since STL303 is now in a Phase 2 trial, it has already passed initial safety tests in earlier trials. This provides some confidence that the treatment is generally safe for humans, but further research will help confirm these findings. Overall, the available data suggests STL303 is generally well-tolerated, but ongoing studies will further clarify its safety.12345

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

Unlike the standard of care for macular degeneration, which often involves anti-VEGF injections like ranibizumab or aflibercept, STL303 is unique because it targets different pathways that may contribute to vision loss. Researchers are excited about STL303 because it could offer an alternative approach by potentially reducing inflammation or affecting other cellular mechanisms involved in macular degeneration. Additionally, STL303 is being tested at different dose levels to optimize its effectiveness and safety, which could lead to more personalized treatment options for patients.

What evidence suggests that STL303 might be an effective treatment for macular degeneration?

Research has shown that STL303 may help treat geographic atrophy (GA), a type of vision loss associated with age-related macular degeneration (AMD). In an earlier study, 71.4% of patients taking moderate doses of STL303 maintained stable vision over six weeks. This trial will evaluate different dose levels of STL303, with participants receiving either dose level 1, dose level 2, or a placebo. While more information is needed to fully understand its effects, these early results offer promise for those experiencing vision loss due to GA from AMD.12346

Are You a Good Fit for This Trial?

This trial is for adults diagnosed with geographic atrophy caused by age-related macular degeneration, a condition that leads to vision loss in the center of the eye. Participants should not have other major eye diseases or conditions that could interfere with the study.

Inclusion Criteria

Microperimetry criteria: able to detect fixation target, fixation losses ≤20%, willing and able to undertake assessment per Investigator
Able to provide written informed consent and comply with study protocol including visits, examinations, dosing diary
Confirmed presence of any hyper-autofluorescence pattern in junctional zone of GA; absence excludes
See 18 more

Exclusion Criteria

Platelet count <75000 cells/mm3
Hemoglobin <8 gm/dL
Ongoing participation in any other clinical study
See 23 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive STL303 or placebo over a period of 104 weeks to assess efficacy and safety

104 weeks
Visits at weeks 0, 4, 12, 26, 52, 78, and 104

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • STL303

Trial Overview

The study is testing a new drug called STL303 compared to a placebo (inactive treatment) to see if it is safe and effective for treating geographic atrophy from AMD. Participants are randomly assigned to receive either STL303 or placebo.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Placebo Group

Group I: STL303 dose level 2Experimental Treatment1 Intervention
Group II: STL303 dose level 1Experimental Treatment1 Intervention
Group III: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sitala Bio LTD

Lead Sponsor

Citations

A Phase 2 Study of STL303 in Adults With Geographic ...

The purpose of this clinical research study is to look at how safe STL303 is and whether it works when given to people with Geographic ...

Sylentis, a PharmaMar Group company, announces the ...

71.4% of patients in the middle dose levels maintained visual acuity over the 6-week study period. The study evaluated the preliminary efficacy and safety of ...

Photobiomodulation efficacy in age-related macular ... - PMC

In this meta-analysis evaluating PBM therapy for patients with dry AMD, there was a statistically significant improvement in visual acuity and ...

A Phase 2 Study of STL303 in Adults With Geographic Atrophy ...

The purpose of this clinical research study is to look at how safe STL303 is and whether it works when given to people with Geographic ...

Age-Related Macular Degeneration

STL303 for Macular Degeneration ... Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness.

Rethinking Clinical Trials in Age-Related Macular Degeneration

This review highlights the transformative potential of AI in optimizing clinical trial outcomes for patients with nAMD or GA secondary to AMD.