Actively Recruiting

Phase 1
Phase 2
Age: 50Years +
All Genders
NCT05197270

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

Led by 4D Molecular Therapeutics · Updated on 2026-02-12

215

Participants Needed

25

Research Sites

472 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Phase 1/2 dose-escalation and randomized, controlled, masked expansion trial in adults with wet AMD undergoing active anti-VEGF treatment. Substudies will evaluate the safety and tolerability of 4D-150 contralateral eye dosing and characterize vector shedding.

CONDITIONS

Official Title

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

Who Can Participate

Age: 50Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be 50 years of age or older
  • Diagnosed with choroidal neovascularization secondary to age-related macular degeneration confirmed by reading center
  • Best corrected visual acuity (BCVA) of 34 ETDRS letters (~20/200) or better in the contralateral eye
  • Central subfield thickness and/or presence of subretinal or intraretinal fluid requiring ongoing anti-VEGF therapy in the study eye, confirmed by SD-OCT and reading center
  • Study eye suitable for intravitreal injection
  • Ability to perform visual and retinal function tests and comply with protocol procedures
  • Currently receiving anti-VEGF treatment in the study eye and demonstrated clinical response within 12 months prior to screening
  • Agree to use barrier methods during intercourse for 6 months after 4D-150 administration; sexually active males must not father a child or donate sperm during this period
  • Medical records documenting anti-VEGF therapy history for at least 12 months prior to screening
  • Provide written informed consent
  • For Contralateral Eye Sub-study: received 4D-150 in study eye-1 at least 6 months prior to screening
  • Macular neovascularization secondary to AMD in study eye-2 confirmed by imaging
  • History of at least one anti-VEGF injection in study eye-2 within 6 months prior to screening
  • BCVA between 25 and 83 ETDRS letters in study eye-2
  • Study eye-2 suitable for intravitreal injection
  • BCVA of 34 ETDRS letters or better in previously treated study eye-1
  • Ability to comply with protocol procedures and visits
  • Agree to use barrier methods as above
  • Provide written informed consent
  • For Shedding Substudy: 50 years or older
  • Diagnosed with macular neovascularization secondary to AMD confirmed by imaging
  • BCVA between 10 and 83 ETDRS letters in study eye at screening
  • BCVA of 34 ETDRS letters or better in contralateral eye
  • Currently receiving anti-VEGF treatment in study eye with at least one injection in last 6 months
  • Study eye suitable for intravitreal injection
  • Ability to perform visual and retinal function tests and comply with protocol procedures
  • Agree to use barrier methods as above
  • Provide written informed consent
Not Eligible

You will not qualify if you...

  • None explicitly stated in the eligibility criteria

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 25 locations

1

Barnet Delaney Perkins Eye Center

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

California Retina Consultants

Oxnard, California, United States, 93036

Actively Recruiting

3

Retinal Consultants Medical Group

Sacramento, California, United States, 95841

Actively Recruiting

4

Colorado Retina Associates

Lakewood, Colorado, United States, 80288

Actively Recruiting

5

Rand Eye Institute

Deerfield Beach, Florida, United States, 33064

Suspended

6

Retina Vitreous Consultants, LLP DBA Retina Group of Florida

Fort Lauderdale, Florida, United States, 33308

Active, Not Recruiting

7

Vitreo Retinal Associates

Gainesville, Florida, United States, 32607

Actively Recruiting

8

Florida Eye Associates

Melbourne, Florida, United States, 32901

Actively Recruiting

9

Retinal Specialty Institute

Pensacola, Florida, United States, 32503

Actively Recruiting

10

Retina Vitreous Associates of Florida

Tampa, Florida, United States, 33607

Actively Recruiting

11

University Retina and Macula Associates

Oak Forest, Illinois, United States, 60452

Actively Recruiting

12

Retina Partners Midwest

Carmel, Indiana, United States, 46290

Actively Recruiting

13

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States, 21740

Actively Recruiting

14

Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

15

Sierra Eye Associates

Reno, Nevada, United States, 89502

Actively Recruiting

16

Western Carolina Retinal Associates

Asheville, North Carolina, United States, 28803

Withdrawn

17

Verum Research, LLC

Eugene, Oregon, United States, 97401

Actively Recruiting

18

Mid Atlantic Retina

Bethlehem, Pennsylvania, United States, 18017

Actively Recruiting

19

Palmetto Retina Center, LLC

West Columbia, South Carolina, United States, 29169

Actively Recruiting

20

Tennessee Retina

Nashville, Tennessee, United States, 37203

Actively Recruiting

21

Austin Clinical Research

Austin, Texas, United States, 78750

Actively Recruiting

22

Valley Retina Institute, PA

McAllen, Texas, United States, 78503

Actively Recruiting

23

Retina Consultants of Texas

The Woodlands, Texas, United States, 77384

Withdrawn

24

Pacific Northwest Retina LLC

Bellevue, Washington, United States, 98004

Withdrawn

25

Emanuelli Research and Development Center, LLC

Arecibo, Puerto Rico, Puerto Rico, 00612

Actively Recruiting

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Research Team

4

4DMT Patient Advocacy

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

10

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