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The Role of Inflammation in AMD and Related Disorders

Sponsor
Unity Health Toronto (Other)
Overall Status
Unknown status
CT.gov ID
NCT02588378
Collaborator
(none)
200
Enrollment
1
Location
61
Duration (Months)
3.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: multi-modal cSLO imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions
Study Start Date :
Apr 1, 2015
Anticipated Primary Completion Date :
May 1, 2020
Anticipated Study Completion Date :
May 1, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Visualization of RPE damage and presumptive immune cells [8 months]

    Qualitative

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St Michael's Hospital Toronto Ontario Canada M5B 1W8

Sponsors and Collaborators

  • Unity Health Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Unity Health Toronto
ClinicalTrials.gov Identifier:
NCT02588378
Other Study ID Numbers:
  • 15-052
First Posted:
Oct 27, 2015
Last Update Posted:
May 23, 2019
Last Verified:
May 1, 2019
Additional relevant MeSH terms:
Macular Degeneration

Study Results

No Results Posted as of May 23, 2019