Retinal DegenerationNCT05355415
Adaptive Optics Imaging of Outer Retinal Diseases
An observational study of Retinal Degeneration and Age-Related Macular Degeneration, run by Food and Drug Administration (FDA) at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Retinal Degeneration, Age-Related Macular Degeneration, Retinitis Pigmentosa
- What is being tested?
- Adaptive optics imaging
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Aug 2021to 30 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Adult, Older adult
Study population: All study participants will be recruited from the NIH patient population.
Who may be able to join
- Are 21 years of age or older,
- Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
- Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
- Have been diagnosed with outer retinal disease or condition (Cohort 2).
Who cannot join
- Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
- Have visual correction outside of the range +4 diopters (D) to -8 D,
- Have a history of adverse reaction to mydriatic drops,
- Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
- Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
NIH Clinical Center
Bethesda, Maryland, 20810
Catherine Cukras, M.D., Ph.D., 301-435-5061, cukrasc@nei.nih.gov
- Recruiting
Food and Drug Administration
Silver Spring, Maryland, 20993
Daniel X Hammer, Ph.D., 301-796-9320, daniel.hammer@fda.hhs.gov
Zhuolin Liu, Ph.D., 301-796-7914, zhuolin.liu@fda.hhs.gov
About this study
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.
Read the 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.
- Conditions
- Retinal Degeneration, Age-Related Macular Degeneration, Retinitis Pigmentosa, Hydroxychloroquine Retinopathy, Usher Syndromes, Late-Onset Retinal Degeneration
- Being tested
- Adaptive optics imaging
- Medical subject headings
- Retinal Degeneration, Macular Degeneration, Retinitis Pigmentosa, Usher Syndromes, Late-Onset Retinal Degeneration, Cone Dystrophy, Cone-Rod Dystrophies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptive optics imagingDevice
Adaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Adaptive optics imaging | |
| Healthy control | Age-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases. Receives: Device: Adaptive optics imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Photoreceptor (PR) density
PR density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes or average AOSLO frames.
Measured: PR density will be calculated once at the AO imaging session in which PRs are the target.
Retinal pigment epithelial (RPE) cell density
RPE cell density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes.
Measured: RPE cell density will be calculated once at the AO imaging session in which RPE cells are the target.
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.
Measured: 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
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start27 Aug 2021
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Food and Drug Administration (FDA)
- Sponsor type
- US federal agency
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, Daniel X. Hammer, Food and Drug Administration (FDA)
- Investigators
- Daniel X Hammer, Ph.D., Principal investigator, Food and Drug Administration (FDA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355415
- Sponsor's protocol ID
- 2019-CDRH-074
- Status last verified
- May 2026
- First submitted
- 19 Apr 2022
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified AO images will be shared with external academic collaborators.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Optics Imaging of Outer Retinal Diseases
- ClinicalTrials.gov ID
- NCT05355415
- Acronym / sponsor ID
- 2019-CDRH-074
- Conditions
- Retinal Degeneration, Age-Related Macular Degeneration, Retinitis Pigmentosa, Hydroxychloroquine Retinopathy, Usher Syndromes, Late-Onset Retinal Degeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Food and Drug Administration (FDA)US federal agency
- Collaborators
- National Eye Institute (NEI)
- Study start
- 27 Aug 2021 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2028 (estimated)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outer retinal disease | – | Device: Adaptive optics imagingSubjects 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 | – | Device: Adaptive optics imagingAge-matched healthy control subjects will undergo the same AO imaging procedures as subjects with outer retinal diseases. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All study participants will be recruited from the NIH patient population.
Key inclusion criteria (4 listed)
- Are 21 years of age or older,
- Have the ability to cooperate with instructions during adaptive optics imaging (similar to instructions given during a clinical eye exam),
- Have the ability to understand and sign an informed consent. (Non-English speaking participants will not be enrolled into the study), and
- Have been diagnosed with outer retinal disease or condition (Cohort 2).
Key exclusion criteria (5 listed)
- Have a condition which prevents adequate images from being obtained (e.g. unstable fixation or media opacity),
- Have visual correction outside of the range +4 diopters (D) to -8 D,
- Have a history of adverse reaction to mydriatic drops,
- Have a predisposition to (i.e., narrow iridocorneal angle) or any history of acute angle closure glaucoma (AACG), or
- Are working under the direct supervision of Drs. Hammer, Cukras and Liu, or any of the NIH/NEI AIs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adaptive optics imagingAdaptive optics scanning laser ophthalmoscopy (AOSLO) and adaptive optics - optical coherence tomography (AO-OCT) retinal imaging | Device | Healthy control, Outer retinal disease |
Primary outcome
Photoreceptor (PR) density
Time frame: PR density will be calculated once at the AO imaging session in which PRs are the target.
PR density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes or average AOSLO frames.
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 density will be calculated at specific retinal eccentricities from cells counted in average AO-OCT volumes.
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.
RPE cell organelle motility will be calculated from the decorrelation time constant for cells segmented from a sequence of AO-OCT volumes.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. De-identified AO images will be shared with external academic collaborators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daniel X Hammer, Ph.D. principal investigator
Food and Drug Administration (FDA)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Degeneration and Age-Related Macular Degeneration, run by Food and Drug Administration (FDA) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel X Hammer, Ph.D. (301-796-9320, daniel.hammer@fda.hhs.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.