4D-150 for Age-Related Macular Degeneration

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: 4D Molecular Therapeutics

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment

Is the drug 4D-150 IVT, also known as Aflibercept IVT, a promising treatment for Age-Related Macular Degeneration?Yes, the drug Aflibercept IVT shows promise as a treatment for Age-Related Macular Degeneration. Research indicates that it can improve vision and reduce fluid in the eye, which are positive outcomes for patients with this condition.¹ ³ ⁴ ⁵ ⁶

What safety data is available for 4D-150 in treating age-related macular degeneration?The safety data for 4D-150, also known as ziv-aflibercept or aflibercept (Eylea), includes several studies. One study on a patient with exudative age-related macular degeneration reported no adverse events after intravitreal injection of ziv-aflibercept, indicating short-term safety. Another study on diabetic macular edema evaluated the safety of ziv-aflibercept over 48 weeks. Additionally, a study on aflibercept for retinitis pigmentosa-associated cystoid macular oedema assessed safety over 12 months. A one-year study on aflibercept for neovascular age-related macular degeneration also contributes to the safety profile. Overall, these studies suggest a favorable safety profile for intravitreal administration of ziv-aflibercept and aflibercept in related conditions.¹ ² ³ ⁵ ⁶

What data supports the idea that 4D-150 for Age-Related Macular Degeneration is an effective drug?The available research shows that 4D-150, also known as aflibercept or ziv-aflibercept, is effective for treating Age-Related Macular Degeneration. One study reported that patients experienced improvements in vision and a reduction in fluid in the eye after receiving the drug. Another study found that ziv-aflibercept was effective for patients who did not respond to other treatments like bevacizumab and ranibizumab. These studies indicate that 4D-150 can improve vision and is a good option for those who haven't had success with other treatments.¹ ² ³ ⁴ ⁵

Do I have to stop taking my current medications for the trial?The trial does not specify if you need to stop taking your current medications. However, you must be currently receiving anti-VEGF treatment in the study eye to participate.

Eligibility Criteria

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.

Inclusion Criteria

I am 50 years old or older.

I have been diagnosed with wet AMD.

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

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

Treatment Details

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.

8Treatment groups

Experimental Treatment

Active Control

Group I: 4D-150 Steroid OptimizationExperimental Treatment1 Intervention