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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

Must not have

Prior treatment with photodynamic therapy or retinal laser in the study eye

Any condition preventing visual acuity improvement in the study eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

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.

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.

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

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I am 50 years old or older.

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I have been diagnosed with wet AMD.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had photodynamic therapy or retinal laser treatment in my study eye.

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I have a condition that stops my vision from getting better in one eye.

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I do not have eye conditions that would affect my participation in a study.

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I have had uveitis in one or both of my eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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