The Role of Inflammation in AMD and Related Disorders

NCT02588378 | Unknown

• 1 other identifier: 15-052
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Visualization of RPE damage and presumptive immune cells

  Qualitative

  8 months

Study Arms (9)

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

Interventions

multi-modal cSLO imaging PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Any tentative clinical diagnosis of the following:
• Early dry AMD (drusen) with clinical suspicion of CNV
• Late dry AMD (GA) with clinical suspicion of CNV
• Reticular Pseudodrusen with clinical suspicion of CNV
• Polypoidal choroidal vasculopathy
• Retinal Angiomatous Proliferation
• Central Serous Retinopathy
• RPE detachment
• Conversion to wet AMD (CNV)
• Decade matched controls
• Subjects \> 18 years of age
• Best corrected visual acuity (BCVA) of 20/32 or better

You may not qualify if:

• 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).
• Suspect diagnosis of AMD, RPD, PCV, RAP, CSR or RPED
• Family history of AMD
• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Shelley Boyd, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Boyd, MD

CONTACT

416-864-6060; BoydS@smh.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 27, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 23, 2019

Record last verified: 2019-05

Locations

CA (1)