Recruiting

Observational Study

Sponsor:

Johns Hopkins University

Code:

NCT04505618

Conditions

Diabetic Retinopathy

Retinal Vein Occlusion

Hypertension,Essential

Retinal Vascular Disorder

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Swept-Source (SS) OCT Angiography

Spectral-Domain (SD) OCT Angiography

Fundus Imaging

Axial Length Measurement Device

Study Details

Brief summary:

This study will perform a prospective, longitudinal analysis of clinical and imaging findings from normal controls and subjects with retinal vascular disease to better define the diagnostic imaging criteria that signify change in disease stage. This includes disease progression in early stages of disease or disease regression with appropriate standard-of-care treatment.

Conditions

Diabetic Retinopathy

Retinal Vein Occlusion

Hypertension,Essential

Retinal Vascular Disorder

Study ID

NCT04505618

Start date

Oct 1, 2019

Status verified date

Jun, 2026

Completion date

Sep 1, 2027

Anticipated

Primary completion date

Jun 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Exclusion Criteria:

  • Both subjects with diseases and controls:
  • Children (age<18)
  • Pregnant females
  • Developmentally delayed subjects
  • Subjects unable to provide informed consent
  • Inability to cooperate with tests and study instructions
  • Images with motion artifact or signal strength < 7
  • History of glaucoma
  • History of age-related macular degeneration
  • History of any visually significant eye disease
  • History of proliferative diabetic retinopathy
  • History of any inflammatory disease
  • History of heart disease
  • History of thyroid disease.
  • Additional criteria for controls:
  • History of any type of Diabetes Mellitus
  • History of any type of Hypertension

Study Design

Enrollment

1050 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Controls

Subjects in this group do not have any ocular pathology and are also not hypertensive. Some subjects in this arm will undergo retinal vascular reactivity assessments.

other: Diabetics with and without Diabetic Retinopathy Only

Subjects in this group only have diabetes with or without diabetic retinopathy. Some subjects in this arm will undergo retinal vascular reactivity assessments.

other: Hypertension Only

Subjects in this group only have hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

other: Diabetics w/ or w/o Diabetic Retinopathy & Hypertension

Subjects in this group have diabetes with or without diabetic retinopathy and hypertension with or without ocular pathology related to hypertension. Some subjects in this arm may undergo retinal vascular reactivity assessments.

Interventions

Swept-Source (SS) OCT Angiography

Non-invasive, minimal risk, ocular imaging study

Spectral-Domain (SD) OCT Angiography

Non-invasive, minimal risk, ocular imaging study

Fundus Imaging

Non-invasive, minimal risk, ocular imaging study

Axial Length Measurement Device

Non-invasive, minimal risk, ocular imaging study

Primary outcome measure

  • Correlation of Imaging [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Amir H Kashani, MD, PhD

410-502-2789akashan1@jhmi.edu

Ana C Martinez, MPH

410-502-2789acollaz5@jhmi.edu

Locations

Wilmer Eye Institute

Recruiting

Baltimore, Maryland, United States, 21287

Contacts

Ana Collazo Martinez

410-502-5052acollaz5@jhmi.edu

Principal Investigator:

Amir H Kashani, MD, PhD

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-17.