The Role of Inflammation in AMD and Related Disorders

Age-Related Macular Degeneration Clinical Trial

Official title:

In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02588378
• Other study ID #: 15-052
• Status: Recruiting
• Start date: April 2015
• Est. completion date: May 2020

Study information

• Verified date: May 2019
• Source: St. Michael's Hospital, Toronto
• Contact: Shelley Boyd, MD
• Phone: 416-864-6060
• Email: BoydS[@]smh.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 2020
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Procedure:
• multi-modal cSLO imaging

Locations

Country	Name	City	State
Canada	St Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Michael's Hospital, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visualization of RPE damage and presumptive immune cells	Qualitative	8 months