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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 belowSelect...
I am 50 years old or older.
Select...
I have been diagnosed with wet AMD.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had photodynamic therapy or retinal laser treatment in my study eye.
Select...
I have a condition that stops my vision from getting better in one eye.
Select...
I do not have eye conditions that would affect my participation in a study.
Select...
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
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
Schonmei Lee, MDStudy Director4D Molecular Therapeutics
4 Previous Clinical Trials
163 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had photodynamic therapy or retinal laser treatment in my study eye.I have a condition that stops my vision from getting better in one eye.I am 50 years old or older.I am being treated with anti-VEGF for my eye and it's working.I have been diagnosed with wet AMD.I've had at least 6 anti-VEGF injections in my eye in the last year and they worked.I do not have eye conditions that would affect my participation in a study.I have had uveitis in one or both of my eyes.I have been diagnosed with wet AMD.
Research Study Groups:
This trial has the following groups:- Group 1: 4D-150 Dose Expansion Control
- Group 2: 4D-150 Population Extension Dose 3
- Group 3: 4D-150 Dose Expansion Dose 1
- Group 4: 4D-150 Dose Expansion Dose 2
- Group 5: 4D-150 Dose Escalation up to 4 dose levels
- Group 6: 4D-150 Steroid Optimization
- Group 7: 4D-150 Population Extension Dose 1
- Group 8: 4D-150 Population Extension Dose 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.