4D-150 in Patients With Neovascular (Wet) Age-Related Macular Degeneration

Launched by 4D MOLECULAR THERAPEUTICS · Jan 5, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called 4D-150 for patients with a specific eye condition known as neovascular (wet) age-related macular degeneration (AMD). This condition can cause vision loss and is often treated with medications that block a substance called VEGF. The trial is currently recruiting adults aged 50 and older who are already receiving anti-VEGF treatment and have shown a positive response to it in the past year. Participants will be closely monitored to see if the new treatment improves their vision compared to standard care.

To be eligible for this trial, participants must be at least 50 years old and have a diagnosis of macular choroidal neovascularization (CNV) due to AMD. They also need to have a certain level of vision and must not have any other eye conditions that could affect their vision or the trial outcomes. If you choose to participate, you can expect regular check-ups and assessments to track your vision and any potential side effects from the new treatment. This trial aims to find out if 4D-150 can provide better results for patients with wet AMD and help improve their quality of life.

Gender

ALL

Eligibility criteria

• • 50 years of age
• • Diagnosed with macular CNV secondary to AMD
• • BCVA ETDRS Snellen equivalent for dose escalation and contralateral eye between \~20/32 and \~20/320, or for dose expansion and population extension between \~20/25 and\~20/200, for steroid optimization and shedding sub-study between \~20/25 and \~20/640
• • Currently receiving anti-VEGF treatment in the study eye and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening
• • Contralateral Eye Sub-study-Specific Criteria: Received 4D-150 in study eye-1 at least 6 months prior to Contralateral Sub-study Screening Visit
• • Contralateral Eye Sub-study-specific Exclusion: Prior adverse event related to 4D-150, required modifications to or reinitiated protocol specified corticosteroid regimen/taper in study eye-1, signs and symptoms of noninfectious intraocular inflammation in either eye
• • -
• Shedding Sub-study-specific Inclusion Criteria:
• • S-1. ≥50 years of age S-2. Diagnosed with macular CNV secondary to AMD S-3. BCVA ETDRS Snellen equivalent between \~20/640 and 20/25 S-5. Currently receiving anti-VEGF and has demonstrated a clinical response consistent with anti-VEGF activity within 12 months prior to screening
• Shedding Sub-study-specific Exclusion Criteria:
• • Any condition preventing visual acuity improvement in the study eye
• • Prior treatment with photodynamic therapy or retinal laser in the study eye
• • History of uveitis in either eye
• • Any other pre-existing eye conditions or surgical complications that would preclude participation in an interventional clinical trial or interfere with the interpretation of study endpoints