The Role of Inflammation in AMD and Related Disorders

Unity Health Toronto

Status: Unknown

Conditions: Age-Related Macular Degeneration

Treatments: Procedure: multi-modal cSLO imaging

Study type: Observational

Funder types: Other

Identifiers

NCT02588378

15-052

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

200 participants in 9 patient groups

Early dry AMD (no GA)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Late dry AMD (with GA)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Reticular Pseudodrusen (RPD)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Polypoidal Choroidal Vasculopathy (PCV)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Retinal Angiomatous Proliferaion (RAP)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Central Serous Retinopathy (CSR)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

RPE Detachment (RPED)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

New onset CNVM (wet AMD)

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging

Healthy (non-AMD) controls

Description:

multi-modal cSLO imaging

Treatment:

Procedure: multi-modal cSLO imaging