Adaptive Optics Imaging of Outer Retinal Diseases

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
Food and Drug Administration (FDA)
Study ID
NCT05355415
Status
Recruiting
Apply to this trial

Conditions

  • Age-Related Macular Degeneration
  • Cone Dystrophy
  • Cone Rod Dystrophy
  • Hydroxychloroquine Retinopathy
  • Late-Onset Retinal Degeneration
  • Retinal Degeneration
  • Retinitis Pigmentosa
  • Rod Cone Dystrophy
  • Rod Dystrophy
  • Usher Syndromes

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Adaptive optics imaging — DEVICE
    Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging

Study Details

The objective of the study is to collect adaptive optics (AO) retinal images from human subjects with outer retinal diseases (diseases of the outer retina including photoreceptor, retinal pigment epithelium (RPE), basement membrane or choroidal pathologies) to develop new diagnostic methods, biomarkers, and clinical endpoints.

Key Dates

Start date
Aug 27, 2021
Status verified
May 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2028

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Outer retinal disease
    Subjects with outer retinal disease affecting the photoreceptor-retinal pigment epithelium complex will be classified by clinical exam by an experienced retina specialist. Outer retinal disease subjects will undergo adaptive optics (AO) imaging of several macular locations.
  • Arm: Healthy control
    Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases.

Primary Outcome Measure

Photoreceptor (PR) density [ Time Frame: PR density will be calculated once at the AO imaging session in which PRs are the target. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
NIH Clinical CenterBethesdaMaryland20810
Catherine Cukras, M.D., Ph.D.
[email protected]
301-435-5061
Food and Drug AdministrationSilver SpringMaryland20993
Daniel X Hammer, Ph.D.
[email protected]
301-796-9320
Zhuolin Liu, Ph.D.
[email protected]
301-796-7914

Find similar trials in Bethesda, MD

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina
By research site
NIH Clinical Center· Bethesda, MDFood and Drug Administration· Silver Spring, MD

Related Studies