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4D-150 for Age-Related Macular Degeneration

Phase 1 & 2

Recruiting

Research Sponsored by 4D Molecular Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥50 years of age

Diagnosed with macular CNV secondary to AMD

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 52 weeks

Awards & highlights

Study Summary

This trial is testing a new drug for wet AMD in adults who are already receiving active treatment for the condition.

Who is the study for?

This trial is for adults over 50 with wet Age-Related Macular Degeneration (AMD) who have been treated with at least 6 anti-VEGF injections in the past year and shown improvement. They should have a certain level of vision, not worse than ~20/320. Those with central fovea damage, history of uveitis, or previous specific eye treatments are excluded.Check my eligibility

What is being tested?

The study tests two intravitreal treatments: Aflibercept (an existing drug) and an experimental drug called 4D-150 for wet AMD. It's a Phase 1/2 trial that starts by finding safe doses and then compares the drugs' effects in a controlled setup where participants don't know which treatment they're getting.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks may include eye irritation or discomfort, increased eye pressure, bleeding inside the eye, cataracts formation, retinal detachment or infection from the injection procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 50 years old or older.

Select...

I have been diagnosed with wet AMD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 52 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~52 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence and severity of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs), including clinically significant changes in safety parameters

Secondary outcome measures

Change from baseline in BCVA over time (up to 52 weeks) as assessed using the ETDRS Visual Acuity Chart

Change from baseline in central subfield thickness (CST) over time (up to 52 weeks) measured by spectral domain optical coherence tomography (SD-OCT)

Number of supplemental aflibercept injections over 52 weeks

+2 more

Side effects data

From 2020 Phase 4 trial • 26 Patients • NCT03022292

Retinal detachment

Myelodysplastic syndrome

Pneumonia

100%

80%

60%

40%

20%

Study treatment Arm

IAI Treatment

Trial Design

7Treatment groups

Experimental Treatment

Active Control

Group I: 4D-150 Steroid OptimizationExperimental Treatment1 Intervention