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Monoclonal Antibodies
4D-150 for Diabetic Macular Edema
Phase 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
Demonstrate clinical response to on-study aflibercept injection in the study eye
Diagnosis of DME must be within 2 years of Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 104 weeks
Awards & highlights
Study Summary
This trial tests different doses to see if an adult's DME can be treated safely and effectively.
Who is the study for?
Adults over 18 with Diabetic Macular Edema (DME) diagnosed within the last two years, who've shown improvement after an aflibercept eye injection. Participants must have certain levels of vision in the affected eye and be able to undergo further injections. Those with other causes for macular edema or on recent anti-VEGF/corticosteroid treatments can't join.Check my eligibility
What is being tested?
The trial is testing a new treatment called 4D-150 compared to Aflibercept, both administered through an injection into the eye (IVT). It's designed to see which is better at improving vision for people with DME. Patients are randomly assigned to receive one of these treatments and won't know which they're getting.See study design
What are the potential side effects?
Possible side effects from IVT injections like those being tested could include redness, discomfort or pain at the injection site, increased pressure inside the eye, bleeding in the retina, and possibly infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My eye condition improved after receiving an aflibercept injection.
Select...
I was diagnosed with diabetic macular edema within the last 2 years.
Select...
My vision loss is mainly due to diabetic macular edema.
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My eye can safely receive injections.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 104 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~104 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Annualized number of aflibercept injections in the study eye
Secondary outcome measures
Change from baseline in BCVA as assessed using the ETDRS Visual Acuity Chart
Change from baseline in CST measured by spectral domain optical coherence tomography (SD-OCT)
Mean cumulative number of aflibercept injections over time
+1 moreOther outcome measures
Incidence and severity of treatment-emergent adverse events and serious adverse events, including clinically significant changes in safety parameters
Side effects data
From 2020 Phase 4 trial • 26 Patients • NCT030222924%
Retinal detachment
4%
Myelodysplastic syndrome
4%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
IAI Treatment
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: 4D-150 Part 2 Dose Expansion Dose Level 2Experimental 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 Part 2 Dose Expansion Dose Level 1Experimental Treatment1 Intervention
4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1.
Group III: 4D-150 Part 1 Dose Confirmation Dose Level 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 Part 1 Dose Confirmation Dose Level 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 Part 2 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
301 Total Patients Enrolled
Schonmei Lee, MDStudy Director4D Molecular Therapeutics
4 Previous Clinical Trials
241 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye condition improved after receiving an aflibercept injection.My eye condition may need surgery within the next 2 years.My eyes are healthy enough for detailed exams and tests.I was diagnosed with diabetic macular edema within the last 2 years.My macular edema is not due to diabetic macular edema.My vision loss is mainly due to diabetic macular edema.My eye can safely receive injections.Your vision in the study eye is between 20/320 and 20/25 at the screening.I haven't taken any experimental treatments in the last 3 months or 5 half-lives, whichever is longer.I have had gene or stem cell therapy in my eyes.I haven't taken steroids or immunosuppressants in the last 3 months.I haven't had anti-VEGF treatment in the last 6 months and don't expect to need it during the study.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: 4D-150 Part 2 Dose Expansion Control
- Group 2: 4D-150 Part 1 Dose Confirmation Dose Level 2
- Group 3: 4D-150 Part 2 Dose Expansion Dose Level 2
- Group 4: 4D-150 Part 2 Dose Expansion Dose Level 1
- Group 5: 4D-150 Part 1 Dose Confirmation Dose Level 1
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the various locations that this clinical trial is overseen from?
"Currently, 7 clinical trial sites are operational for this study. These include locations in Hagerstown, Eugene and Erie amongst other areas. For participant convenience, it is advised to select the nearest facility available to reduce travel costs associated with participation."
Answered by AI
Has the FDA greenlit 4D-150 Part 1 Dose Confirmation Dose Level 1?
"This experimental drug has been evaluated for safety in a Phase 2 trial, so it received an assessment of 2 on the 1-3 scale. However, there is not yet evidence to support its efficacy."
Answered by AI
Is there an ongoing effort to find participants for this clinical investigation?
"According to the most up-to-date information on clinicaltrials.gov, this research trial is still seeking participants. The original post was dated August 9th 2023 with alterations being made as late as August 29th 2023."
Answered by AI
How many research participants are currently engaged in this trial?
"In order to commence the trial, 72 people who meet the predetermined requirements must be enrolled. The two locations that are hosting this investigation are Cumberland Valley Retina Consultants in Hagerstown and Verum Research LLC in Eugene, Oregon."
Answered by AI
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