Optical Coherence Tomography Angiography in Subjects With Retinal Vascular Disease
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 Start (Actual) 1 October 2019
🗓️ Primary Completion (Estimated) 1 June 2025
✅ Study Completion (Estimated) 1 September 2025
👥 Enrollment (Estimated) 1050
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Baltimore, Maryland, United States

📋 Eligibility Criteria

Description

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
Ages Eligible for Study: 18 Years to 99 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 5 August 2020
  • First Submitted that Met QC Criteria 5 August 2020
  • First Posted 10 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 14 August 2023
  • Last Update Posted 16 August 2023
  • Last Verified August 2023