The Role of Inflammation in AMD and Related Disorders

In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions

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.

Study Overview

• Status: Unknown
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Procedure: multi-modal cSLO imaging

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • Recruiting
      • St Michael's Hospital
      • Contact: Shelley Boyd, MD; Phone Number: 2893 416-864-6060; Email: BoydS@smh.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Male or female, 18 years of age or older, able to understand the study protocol and provide informed consent.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visualization of RPE damage and presumptive immune cells	Qualitative	8 months

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Investigators: Principal Investigator: Shelley Boyd, MD, Unity Health Toronto

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): May 1, 2020

Study Registration Dates

• First Submitted: October 26, 2015
• First Submitted That Met QC Criteria: October 26, 2015
• First Posted (Estimate): October 27, 2015

Study Record Updates

• Last Update Posted (Actual): May 23, 2019
• Last Update Submitted That Met QC Criteria: May 21, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 15-052