RECRUITING

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

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Conditions

Neovascular Age-related Macular Degenerationoptical coherence tomography

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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

Home optical coherence tomography- guided treatment versus treat and extend for the management of neovascular age-related macular degeneration.

Official Title

Home OCT-Guided Treatment Versus Treat and Extend for the Management of Neovascular AMD

Quick Facts

Study Start:2023-11-09
Study Completion:2027-07-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05904028

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 ≥ 50 years
  2. * Have the capacity to consent on his/her own behalf
  3. * Able to successfully and independently complete at least one self-scanning session on the Home OCT device located at the enrolling clinical site
  4. * Willing to perform once daily Home OCT monitoring tests for 2 years without significant interruption (such as travel of more than 14 days)
  5. * Best corrected E-ETDRS visual acuity ≥24 ETDRS letters (approximately 20/320 or better (Snellen))
  6. * Previously untreated, active macular neovascularization (MNV) lesion (i.e., any intraretinal or subretinal fluid within the center 3x3 mm area on OCT) secondary to age-related macular degeneration
  7. * ≥ 1 intermediate drusen (\>63 microns) in either eye OR late AMD (MNV or macular atrophy) in the contralateral eye
  8. * Previous treatment for MNV (intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent, or any other AMD therapy)
  9. * Prior treatment with intravitreal injection of any anti-VEGF or anti-VEGF/anti-Ang2 agent or with macular laser for any indication
  10. * Treatment with intravitreal corticosteroids within the last 6 months
  11. * Any condition that may preclude adequate imaging of the macula (e.g., dense cataract or other media opacity, severe ptosis)
  12. * MNV due to other causes, such as ocular histoplasmosis, central serous choroidopathy, or pathologic myopia
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Locations (Sites)

Kent W. Small, MD, AMC
Glendale, California, 91203-1971
United States
Loma Linda University
Loma Linda, California, 92354
United States
East Bay Retina Consultants, Inc.
Oakland, California, 94609
United States
Southern California Desert Retina Consultants, Inc.
Palm Desert, California, 92211
United States
UC Davis Health Eye Center
Sacramento, California, 95817
United States
Macula Retina Vitreous Institute
Torrance, California, 90503
United States
Bay Area Retina Associates A Medical Group
Walnut Creek, California, 94598
United States
Retina Consultants
Manchester, Connecticut, 06042
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
University of Florida- Jacksonville
Jacksonville, Florida, 32209
United States
Florida Retina Institute, James A. Staman, MD, PA- Jacksonville
Jacksonville, Florida, 32216
United States
Southeast Eye Institute, P.A. dba Eye Associates of Pinellas
Pinellas Park, Florida, 33782-4418
United States
Retina Associates of Sarasota
Sarasota, Florida, 34233
United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609
United States
Southeast Retina Center, P.C.
Augusta, Georgia, 30909
United States
The Trustees of Indiana University
Indianapolis, Indiana, 46202
United States
Midwest Eye Institute
Indianapolis, Indiana, 46290
United States
Wolfe Clinic, P.C.- West Des Moines
West Des Moines, Iowa, 50266
United States
Mid-America Retina Consultants, P.A.
Overland Park, Kansas, 66211
United States
Elman Retina Group, BA
Baltimore, Maryland, 21237
United States
Johns Hopkins University
Baltimore, Maryland, 21287
United States
Valley Eye Physicians and Surgeons
Ayer, Massachusetts, 01432
United States
Joslin Diabetes Center
Boston, Massachusetts, 02215
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
United States
The Retina Institute
St. Louis, Missouri, 63128
United States
Associated Retinal Surgeons d/b/a Mid Atlantic Retina
Cherry Hill, New Jersey, 08034
United States
Retina Associates of Western NY, P.C.
Rochester, New York, 14620
United States
The Cleveland Clinic Foundation DBA Cleveland Clinic Lerner College of Medicine
Cleveland, Ohio, 44120
United States
Retina Vitreous Center
Edmond, Oklahoma, 73013
United States
Verum Research LLC
Eugene, Oregon, 97401
United States
Oregon Health & Science University
Portland, Oregon, 97239
United States
Cascade Medical Research Institute, LLC
Springfield, Oregon, 97477
United States
Retina Vitreous Consultants
Monroeville, Pennsylvania, 15146
United States
The Trustees of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Hilton Head Retina Institute
Hilton Head Island, South Carolina, 29926
United States
Southeastern Retina Associates, P.C.
Knoxville, Tennessee, 37922
United States
Retina Consultants of Texas, PA
Bellaire, Texas, 77401
United States
Baylor College of Medicine, Baylor Eye Physicians and Surgeons
Houston, Texas, 77030-4101
United States
Texas Retina Associates
Lubbock, Texas, 79424
United States
Retinal Consultants of Texas
San Antonio, Texas, 78240
United States
The Board of Regents of the University of Wisconsin System
Madison, Wisconsin, 53705
United States
Eye Clinic of Wisconsin
Wausau, Wisconsin, 54403
United States

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

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 Date2023-11-09
Study Completion Date2027-07-30

Study Record Updates

Study Start Date2023-11-09
Study Completion Date2027-07-30

Terms related to this study

Keywords Provided by Researchers

  • optical coherence tomography

Additional Relevant MeSH Terms

  • Neovascular Age-related Macular Degeneration