Recruiting

Observational Study

Sponsor:

Food and Drug Administration (FDA)

Code:

NCT05355415

Conditions

Retinal Degeneration

Age-Related Macular Degeneration

Retinitis Pigmentosa

Hydroxychloroquine Retinopathy

Usher Syndromes

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Adaptive optics imaging

Study Details

Brief summary:

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.

Conditions

Retinal Degeneration

Age-Related Macular Degeneration

Retinitis Pigmentosa

Hydroxychloroquine Retinopathy

Usher Syndromes

Study ID

NCT05355415

Start date

Aug 27, 2021

Status verified date

May, 2026

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Are 21 years of age or older,
2. Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
3. Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
4. Have been diagnosed with outer retinal disease or condition (Cohort 2).

Exclusion Criteria:

1. Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
2. Have visual correction outside of the range +4 diopters (D) to -8 D,
3. Have a history of adverse reaction to mydriatic drops,
4. Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
5. Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Healthy control

Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases.

Interventions

Adaptive optics imaging

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

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. ]
  • Retinal pigment epithelial (RPE) cell density [ Time Frame: RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target. ]
  • RPE cell organelle motility [ Time Frame: RPE motility will be calculated once at the AO imaging session in which RPE cells are the target. For the reproducibility portion of the study, RPE organelle motility will be quantified three times separated by 1-2 weeks. ]
  • PR cell function [ Time Frame: PR function will be calculated once at the AO imaging session in which PR cells are stimulated. For the reproducibility portion of the study, PR cell function will be quantified three times separated by 1-2 weeks. ]

Central Contacts and Locations

Central contacts

Daniel X Hammer, Ph.D.

301-796-9320daniel.hammer@fda.hhs.gov

Zhuolin Liu, Ph.D.

301-796-7914zhuolin.liu@fda.hhs.gov

Locations

NIH Clinical Center

Recruiting

Bethesda, Maryland, United States, 20810

Contacts

Catherine Cukras, M.D., Ph.D.

301-435-5061cukrasc@nei.nih.gov

Food and Drug Administration

Recruiting

Silver Spring, Maryland, United States, 20993

Contacts

Daniel X Hammer, Ph.D.

301-796-9320daniel.hammer@fda.hhs.gov

Zhuolin Liu, Ph.D.

301-796-7914zhuolin.liu@fda.hhs.gov

More Information

Sponsor

Food and Drug Administration (FDA)

Last update posted

May 8, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Food and Drug Administration (FDA) on 2026-05-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.