RECRUITING

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

Talk to us

Conditions

Neovascular (Wet) Age-Related Macular DegenerationAge-related macular degenerationAMDExudative AMDExudative age-related macular degenerationNeovascular AMDNeovascular age-related macular degenerationWet age-related macular degenerationWet macular degenerationWet AMDwAMDRetinal gene therapyIntravitreal gene therapyGenetic MedicineOcular Gene Therapy

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase 1/2 Dose-Escalation and Randomized, Controlled, Masked Expansion Trial of Intravitreal 4D-150 Gene Therapy in Adults With Neovascular (Wet) Age-Related Macular Degeneration

Quick Facts

Study Start:2021-12-09
Study Completion:2031-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05197270

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Any condition preventing visual acuity improvement in the study eye
  2. * Prior treatment with photodynamic therapy or retinal laser in the study eye
  3. * History of uveitis in either eye
  4. * 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

Contacts and Locations

Study Contact

4DMT Patient Advocacy
CONTACT
(888) 748-8881
clinicaltrials@4DMT.com

Principal Investigator

Jennifer Lee, MD
STUDY_DIRECTOR
4D Molecular Therapeutics

Study Locations (Sites)

Barnet Delaney Perkins Eye Center
Phoenix, Arizona, 85016
United States
California Retina Consultants
Oxnard, California, 93036
United States
Retinal Consultants Medical Group
Sacramento, California, 95841
United States
Colorado Retina Associates
Lakewood, Colorado, 80288
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
United States
Vitreo Retinal Associates
Gainesville, Florida, 32607
United States
Florida Eye Associates
Melbourne, Florida, 32901
United States
Retinal Specialty Institute
Pensacola, Florida, 32503
United States
Retina Vitreous Associates of Florida
Tampa, Florida, 33607
United States
University Retina and Macula Associates
Oak Forest, Illinois, 60452
United States
Retina Partners Midwest
Carmel, Indiana, 46290
United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
United States
Ophthalmic Consultants of Boston & Boston Eye Surgery and Laser Center
Boston, Massachusetts, 02114
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Western Carolina Retinal Associates
Asheville, North Carolina, 28803
United States
Verum Research, LLC
Eugene, Oregon, 97401
United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, 18017
United States
Palmetto Retina Center, LLC
West Columbia, South Carolina, 29169
United States
Tennessee Retina
Nashville, Tennessee, 37203
United States
Austin Clinical Research
Austin, Texas, 78750
United States
Valley Retina Institute, PA
McAllen, Texas, 78503
United States
Retina Consultants of Texas
The Woodlands, Texas, 77384
United States
Pacific Northwest Retina LLC
Bellevue, Washington, 98004
United States

Collaborators and Investigators

Sponsor: 4D Molecular Therapeutics

  • Jennifer Lee, MD, STUDY_DIRECTOR, 4D Molecular Therapeutics

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-09
Study Completion Date2031-01

Study Record Updates

Study Start Date2021-12-09
Study Completion Date2031-01

Terms related to this study

Keywords Provided by Researchers

  • Age-related macular degeneration
  • AMD
  • Exudative AMD
  • Exudative age-related macular degeneration
  • Neovascular AMD
  • Neovascular age-related macular degeneration
  • Wet age-related macular degeneration
  • Wet macular degeneration
  • Wet AMD
  • wAMD
  • Retinal gene therapy
  • Intravitreal gene therapy
  • Genetic Medicine
  • Ocular Gene Therapy

Additional Relevant MeSH Terms

  • Neovascular (Wet) Age-Related Macular Degeneration