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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
No Placebo-Only Group

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 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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups
Experimental Treatment
Active Control
Group I: 4D-150 Steroid OptimizationExperimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group II: 4D-150 Population Extension Dose 3Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose
Group III: 4D-150 Population Extension Dose 2Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group IV: 4D-150 Population Extension Dose 1Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group V: 4D-150 Dose Expansion Dose 2Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group VI: 4D-150 Dose Expansion Dose 1Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group VII: 4D-150 Dose Escalation up to 4 dose levelsExperimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group VIII: 4D-150 Dose Expansion ControlActive Control1 Intervention
Aflibercept at a fixed regimen will be administered.

Find a Location

Who is running the clinical trial?

4D Molecular TherapeuticsLead Sponsor
7 Previous Clinical Trials
239 Total Patients Enrolled
Jennifer Lee, MDStudy Director4D Molecular Therapeutics
Chyong Nien, MDStudy Director4D Molecular Therapeutics
1 Previous Clinical Trials
21 Total Patients Enrolled

Media Library

4D-150 IVT (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05197270 — Phase 1 & 2
Age-Related Macular Degeneration Research Study Groups: 4D-150 Dose Expansion Control, 4D-150 Population Extension Dose 3, 4D-150 Dose Expansion Dose 1, 4D-150 Dose Expansion Dose 2, 4D-150 Dose Escalation up to 4 dose levels, 4D-150 Steroid Optimization, 4D-150 Population Extension Dose 1, 4D-150 Population Extension Dose 2
Age-Related Macular Degeneration Clinical Trial 2023: 4D-150 IVT Highlights & Side Effects. Trial Name: NCT05197270 — Phase 1 & 2
4D-150 IVT (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05197270 — Phase 1 & 2
~51 spots leftby Nov 2025
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