The Role of Inflammation in AMD and Related Disorders

Overview

This prospective, non-therapeutic study will compare the relative utility of multiple ocular imaging modalities in the detection of the cellular immune response in patients with AMD and related disorders.

Full Title of Study: “In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: May 2020

Interventions

  • Procedure: multi-modal cSLO imaging

Arms, Groups and Cohorts

  • Early dry AMD (no GA)
    • multi-modal cSLO imaging
  • Late dry AMD (with GA)
    • multi-modal cSLO imaging
  • Reticular Pseudodrusen (RPD)
    • multi-modal cSLO imaging
  • Polypoidal Choroidal Vasculopathy (PCV)
    • multi-modal cSLO imaging
  • Retinal Angiomatous Proliferaion (RAP)
    • multi-modal cSLO imaging
  • Central Serous Retinopathy (CSR)
    • multi-modal cSLO imaging
  • RPE Detachment (RPED)
    • multi-modal cSLO imaging
  • New onset CNVM (wet AMD)
    • multi-modal cSLO imaging
  • Healthy (non-AMD) controls
    • multi-modal cSLO imaging

Clinical Trial Outcome Measures

Primary Measures

  • Visualization of RPE damage and presumptive immune cells
    • Time Frame: 8 months
    • Qualitative

Participating in This Clinical Trial

Inclusion Criteria STUDY EYE Any tentative clinical diagnosis of the following: 1. Early dry AMD (drusen) with clinical suspicion of CNV 2. Late dry AMD (GA) with clinical suspicion of CNV 3. Reticular Pseudodrusen with clinical suspicion of CNV 4. Polypoidal choroidal vasculopathy 5. Retinal Angiomatous Proliferation 6. Central Serous Retinopathy 7. RPE detachment 8. Conversion to wet AMD (CNV) 9. Decade matched controls Inclusion Criteria CONTROL EYE

  • Subjects > 18 years of age – Best corrected visual acuity (BCVA) of 20/32 or better Exclusion Criteria STUDY/CONTROL EYE: – Patients not able to provide consent for the study. – Patients with a poor view of the fundus due to cataract or vitreous hemorrhage. – Patients < 18 years of age – Patients with known allergy to angiographic dye – Patients with any concurrent unrelated eye diagnosis that would interfere with image acquisition or interpretation (eg advanced diabetic retinopathy, vascular occlusion, uveitis, or others). Exclusion Criteria CONTROL EYE – Suspect diagnosis of AMD, RPD, PCV, RAP, CSR or RPED – Family history of AMD – 2 or more large drusen (>125um) or 20 or more medium drusen (64-124um) – Diabetes – Patients using Plaquenil/Chloroquine/Hydroxychloroquine – Diagnosis of inflammatory disease – Patients with inherited eye disease – Note: patients with a diagnosis of nevi are NOT excluded from this study

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Unity Health Toronto
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Shelley Boyd, MD, Principal Investigator, Unity Health Toronto
  • Overall Contact(s)
    • Shelley Boyd, MD, 416-864-6060, BoydS@smh.ca

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