Age-Related Macular DegenerationNCT02588378
The Role of Inflammation in AMD and Related Disorders
An observational study of Age-Related Macular Degeneration, run by Unity Health Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- multi-modal cSLO imaging
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2015to May 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female, 18 years of age or older, able to understand the study protocol and provide informed consent.
Who may be able to join
- 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
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- Central Serous Retinopathy
- RPE detachment
- Conversion to wet AMD (CNV)
- Decade matched controls
- Subjects > 18 years of age
- Best corrected visual acuity (BCVA) of 20/32 or better
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Michael's Hospital
Toronto, Ontario, M5B 1W8
Shelley Boyd, MD, 416-864-6060 ext. 2893, BoydS@smh.ca
About this study
Official title: In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions
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.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- multi-modal cSLO imaging
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-modal cSLO imagingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Early dry AMD (no GA) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Late dry AMD (with GA) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Reticular Pseudodrusen (RPD) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Polypoidal Choroidal Vasculopathy (PCV) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Retinal Angiomatous Proliferaion (RAP) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Central Serous Retinopathy (CSR) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| RPE Detachment (RPED) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| New onset CNVM (wet AMD) | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging | |
| Healthy (non-AMD) controls | multi-modal cSLO imaging Receives: Procedure: multi-modal cSLO imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visualization of RPE damage and presumptive immune cells
Qualitative
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2020 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shelley Boyd, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588378
- Sponsor's protocol ID
- 15-052
- Status last verified
- May 2019
- First submitted
- 26 Oct 2015
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Visualization of Active Macrophages and Retinal Pigment Epithelium (RPE) Damage in Age Related Macular Degeneration (AMD) & Related Conditions
- ClinicalTrials.gov ID
- NCT02588378
- Acronym / sponsor ID
- 15-052
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Early dry AMD (no GA) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Late dry AMD (with GA) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Reticular Pseudodrusen (RPD) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Polypoidal Choroidal Vasculopathy (PCV) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Retinal Angiomatous Proliferaion (RAP) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Central Serous Retinopathy (CSR) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| RPE Detachment (RPED) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| New onset CNVM (wet AMD) | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
| Healthy (non-AMD) controls | – | Procedure: multi-modal cSLO imagingmulti-modal cSLO imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female, 18 years of age or older, able to understand the study protocol and provide informed consent.
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| multi-modal cSLO imaging | Procedure or surgery | Central Serous Retinopathy (CSR), Early dry AMD (no GA), Healthy (non-AMD) controls, Late dry AMD (with GA), New onset CNVM (wet AMD), Polypoidal Choroidal Vasculopathy (PCV), RPE Detachment (RPED), Reticular Pseudodrusen (RPD), Retinal Angiomatous Proliferaion (RAP) |
Primary outcome
Visualization of RPE damage and presumptive immune cells
Time frame: 8 months
Qualitative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shelley Boyd, MD principal investigator
Unity Health Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by Unity Health Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shelley Boyd, MD (416-864-6060 ext. 2893, BoydS@smh.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visualization of RPE damage and presumptive immune cells (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.