Adaptive Optics Imaging of Outer Retinal Diseases

Age-Related Macular Degeneration Clinical Trial

Official title:

Adaptive Optics Imaging of Outer Retinal Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05355415
• Other study ID #: 2019-CDRH-074
• Status: Recruiting
• Start date: August 27, 2021
• Est. completion date: April 25, 2024

Study information

• Verified date: December 2023
• Source: Food and Drug Administration (FDA)
• Contact: Daniel X Hammer, Ph.D.
• Phone: 301-796-9320
• Email: daniel.hammer[@]fda.hhs.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 25, 2024
• Est. primary completion date: April 25, 2024
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Cone Dystrophy
• Cone Rod Dystrophy
• Macular Degeneration
• Retinal Degeneration
• Retinal Diseases
• Retinitis
• Retinitis Pigmentosa
• Rod Dystrophy
• Usher Syndromes

Intervention

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

Locations

Country	Name	City	State
United States	NIH Clinical Center	Bethesda	Maryland
United States	Food and Drug Administration	Silver Spring	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Food and Drug Administration (FDA)	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photoreceptor (PR) density	PR density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes or average AOSLO frames.	PR density will be calculated once at the AO imaging session in which PRs are the target.
Primary	Retinal pigment epithelial (RPE) cell density	RPE cell density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes.	RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target.
Primary	RPE cell organelle motility	RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes.	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.
Primary	PR cell function	Photoreceptor cell (cone) function will be measured from phase changes between inner segment - outer segment junction and cone outer segment tip signals in a sequence of AO-OCT volumes collected during visible light stimulation.	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.