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Looking for participantsPhase3

Single Intravitreal (IVT) Injection of 4D-150 in Patients With Macular Neovascularization Secondary to Age-Related Macular Degeneration

Sponsor: 4D Molecular Therapeutics

NCT ID: NCT07064759

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
4D-150 IVT (3E10 vg/eye) (biological), EYLEA® (aflibercept) Injection 2 mg (0.05mL) (biological)
How long the study runs
Study runs about 43 months (dates as stated)
About the drug or intervention
4D-150 IVT (3E10 vg/eye) — biological: If randomized to the 4D-150 treatment arm, 4D-150 will be administered at the assigned dose level as a single dose IVT injection on Day 1 · EYLEA® (aflibercept) Injection 2 mg (0.05mL) — biological: Eylea (aflibercept) will be administered at applicable visits
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a single injection into the eye of a treatment called 4D-150 for people with wet age-related macular degeneration (also called neovascular AMD, or nAMD). This is a condition where abnormal blood vessels grow under the part of the eye used for sharp, central vision. The sponsor is 4D Molecular Therapeutics.

Who can take part

  • Aged 50 or older at the time of agreeing to take part
  • Have wet AMD in the study eye, and either have not had anti-VEGF injections into the eye before, or have had no more than 4 of these injections, were diagnosed in the last 6 months, and the treatment helped
  • Have active abnormal blood vessels in or near the centre of the retina, confirmed by eye scans
  • Have already shown a good response to a drug called aflibercept, with stable vision
  • Vision in the study eye between certain limits (roughly 20/320 to 20/32 on a standard eye chart)
  • Central retinal thickness in the study eye of no more than 500 microns

Who may not be able to

  • The abnormal blood vessels are caused by something other than AMD, or there is scarring, tissue wasting, or bleeding in the central part of the retina
  • Have had a detached retina in the study eye
  • Have eye inflammation now or in the past
  • Have glaucoma or high pressure in the eye needing more than 2 eye-drop medicines
  • Have had other eye treatments for the abnormal blood vessels, apart from the allowed anti-VEGF injections
  • Had a serious illness or major surgery in the 28 days before the screening visit
  • Have blood pressure that is not controlled
  • Had a heart attack, acute coronary syndrome, coronary artery procedure, stroke, or mini-stroke in the last 6 months
  • Have an autoimmune condition that could raise the risk of inflammation inside the eye (uveitis)

What taking part involves

  • • A single injection of 4D-150 into the eye (into the vitreous, the gel inside the eye)

Time commitment: Not stated — ask the trial team about visit numbers, study length, and what taking part involves beyond the single eye injection.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
50 Years and over
Who
All
Number of participants
480
Started
2025-07-22
Last checked
2026-04

Plain English Summary

What is this study?

  • • Testing a new treatment for neovascular age-related macular degeneration (namd)
  • • Phase3 - 480 participants
  • • A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Who can take part?

  • • Ages 50 Years and over
  • • Diagnosed with neovascular age-related macular degeneration (namd)

Where?

  • • Bradford - Bradford Royal Infirmary
  • • London - The Retina Clinic London
  • • Sunderland - Sunderland Eye Infirmary

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

A Phase 3, Randomized, Double-Masked, Active-Controlled Trial in Adults with Macular Neovascularization Secondary to Age-Related Macular Degeneration

Neovascular Age-Related Macular Degeneration (nAMD)

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓≥50 years of age at time of consent
  • ✓MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER:
  • ✓Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR
  • ✓Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading...
  • ✓BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening...

Who cannot take part

  • ✗Ocular Conditions:
  • ✗MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central...
  • ✗History of retinal detachment in the study eye
  • ✗History of or presence of active inflammation in either eye
  • ✗Glaucoma or intraocular hypertension requiring more than 2 topical medications for control
See the full criteria
Inclusion Criteria: * ≥50 years of age at time of consent * MNV secondary to nAMD with IVT anti-VEGF treatment history in the study eye, defined as EITHER: 1. Treatment naïve, i.e. no prior IVT anti-VEGF therapy OR 2. Previously treated with no more than 4 IVT anti-VEGF injections due to nAMD and received diagnosis of nAMD no more than 6 months prior to the Screening Visit AND documented evidence of anatomical improvement and visual stability/improvement in response to previous IVT anti-VEGF treatment, as determined by the Investigator * Active subfoveal MNV or juxtafoveal/ extrafoveal MNV with a subfoveal component (where activity is defined as evidence of SRF, IRF, subretinal hyperreflective material, or leakage) identified by fluorescein angiography (FA) or spectral domain optical coherence tomography (SD-OCT) , in the study eye, at the Screening Visit confirmed by the Reading Center * Demonstrated clinical response to aflibercept and functional stability in the study eye as confirmed by the Reading Center * BCVA between 25 and 78 ETDRS letters, inclusive (20/320-20/32 Snellen equivalent) in the study eye at the Screening Visit * CST less than or equal to 500 microns in the study eye at screening visit, confirmed by the central reading center Exclusion Criteria: Ocular Conditions: * MNV due to causes other than nAMD in either eye (Fibrosis, atrophy, or subretinal hemorrhage in the foveal central subfield (1 mm diameter) * History of retinal detachment in the study eye * History of or presence of active inflammation in either eye * Glaucoma or intraocular hypertension requiring more than 2 topical medications for control Ocular Treatments/Interventions: * Any prior or concomitant treatment for MNV or vitreomacular-interface abnormalities, other than allowed prior IVT anti-VEGF in the study eye Systemic Conditions and Considerations: * Major illness or major surgical procedure in the 28 days prior to the Screening Visit * Uncontrolled blood pressure * Acute coronary syndrome, myocardial infarction or coronary artery revascularization, cerebrovascular accident, transient ischemic attack within 6 months of the Screening Visit * History of autoimmune condition that may predispose to the development of uveitis

Where Is This Study? (3 UK sites)

Bradford Royal Infirmary

Bradford BD9 6TB, United Kingdom

Recruiting
Site contact (verified)
Helen DevonportPrincipal Investigator

The Retina Clinic London

London, United Kingdom

Recruiting
Site contact (verified)
Paulo Eduardo Stanga, MDPrincipal Investigator

Sunderland Eye Infirmary

Sunderland SR2 9HP, United Kingdom

Recruiting
Site contact (verified)
Ajay Kotagiri, MBBS, MRCOphth, FRCOphthPrincipal Investigator

How to Get in Touch

4DMT Patient Advocacy

Sponsor contact

CONTACT

(888) 748-8881 clinicaltrials@4DMT.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-04