Clinical trial NCT05355415: Adaptive Optics Imaging of Outer Retinal Diseases
Official title: Adaptive Optics Imaging of Outer Retinal Diseases
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retinal Degeneration
Age-Related Macular Degeneration
Retinitis Pigmentosa
Hydroxychloroquine Retinopathy
Usher Syndromes
Late-Onset Retinal Degeneration
Cone Dystrophy
Cone Rod Dystrophy
Rod Cone Dystrophy
Rod Dystrophy
Lead sponsor: Food and Drug Administration (FDA)
Sponsor class: FED
Collaborators: name: National Eye Institute (NEI)
First posted: 2022-05-02
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants will be recruited from the NIH patient population.

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.

Detailed description: Objective: 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.

Study Population: Up to fifty (50) healthy volunteers without eye disease (Cohort 1) and up to fifty (50) affected participants with any type of outer retinal disease (Cohort 2) will be enrolled.

Design: This is a longitudinal study protocol where participants will be imaged with investigational multimodal AO (mAO) retinal imaging systems that include optical coherence tomography (OCT) and scanning laser ophthalmoscopy (SLO) channels over three years. High resolution OCT and SLO videos will be collected while the instruments automatically detect and correct for image distortion caused by ocular aberrations. In general, videos of different retinal cellular structures will be acquired from several retinal locations using various imaging modes.

Outcome Measures: The primary outcomes for this protocol are development of new diagnostic methods and disease biomarkers, investigation of cellular morphological and functional changes due to various outer retinal diseases, and development of new AO clinical endpoints for novel therapies.

Eligibility criteria: 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.

Primary outcomes:
measure: Photoreceptor (PR) density
timeFrame: PR density will be calculated once at the AO imaging session in which PRs are the target.
measure: Retinal pigment epithelial (RPE) cell density
timeFrame: RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target.
measure: RPE cell organelle motility
timeFrame: 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.
measure: PR cell function
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: NIH Clinical Center
state: Maryland
city: Silver Spring
country: United States
facility: Food and Drug Administration
state: Maryland
Study officials:
affiliation: Food and Drug Administration (FDA)
name: Daniel X Hammer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: