Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05355415
Other study ID # 2019-CDRH-074
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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
Accepts healthy volunteers
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.

Study Design


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.
See also
  Status Clinical Trial Phase
Recruiting NCT05984927 - NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT04005352 - Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON) Phase 3
Withdrawn NCT02873351 - A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration Phase 2
Active, not recruiting NCT02802657 - Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration Phase 4
Not yet recruiting NCT02864472 - Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose Phase 4
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT02035722 - Intravitreal Injections-related Anxiety Phase 2/Phase 3
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Recruiting NCT01048476 - Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT01174407 - Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration N/A
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00345176 - Age-Related Eye Disease Study 2 (AREDS2) Phase 3
Completed NCT02140151 - Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration Phase 1/Phase 2
Completed NCT02555306 - A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration Phase 1/Phase 2
Recruiting NCT04796545 - Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration N/A
Completed NCT03166202 - Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
Completed NCT01397409 - Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD) Phase 2