The Role of Inflammation in AMD and Related Disorders

NCT ID: NCT02588378

Last Updated: 2019-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Age-Related Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Early dry AMD (no GA)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Late dry AMD (with GA)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Reticular Pseudodrusen (RPD)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Polypoidal Choroidal Vasculopathy (PCV)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Retinal Angiomatous Proliferaion (RAP)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Central Serous Retinopathy (CSR)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

RPE Detachment (RPED)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

New onset CNVM (wet AMD)

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Healthy (non-AMD) controls

multi-modal cSLO imaging

multi-modal cSLO imaging

Intervention Type PROCEDURE

Interventions

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multi-modal cSLO imaging

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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


* Subjects \> 18 years of age
* Best corrected visual acuity (BCVA) of 20/32 or better

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shelley Boyd, MD

Role: PRINCIPAL_INVESTIGATOR

Unity Health Toronto

Locations

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St Michael's Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Shelley Boyd, MD

Role: CONTACT

416-864-6060 ext. 2893

Facility Contacts

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Shelley Boyd, MD

Role: primary

416-864-6060 ext. 2893

Other Identifiers

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15-052

Identifier Type: -

Identifier Source: org_study_id

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