The Role of Inflammation in AMD and Related Disorders

U

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:

  • 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

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

Trial contacts and locations

0

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Central trial contact

Shelley Boyd, MD

Data sourced from clinicaltrials.gov

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