An observational study in Geographic Atrophy and Healthy, sponsored by Optina Diagnostics Inc.. Completed at 1 site in Canada. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Optina Diagnostics Inc. · Observational
Among 22 studies in Geographic Atrophy with a site in Canada — 6 open to participants now, 7 under way, 3 of them phase 3. Geographic Atrophy · Canada.
Among the 22 studies in Geographic Atrophy with a site in Canada, this one is one of 4 that started in 2024, is one of 4 observational ones, and was the 20th registered.
188 studies on the registry are indexed under Geographic Atrophy; 52 are open to participants now.
Browse Geographic Atrophy studies →6 of the 22 studies in Geographic Atrophy with a site in Canada are open now. Recruiting first, the newest first:
Novartis Pharmaceuticals · Sites in Canada, United States, Argentina and 16 more countries
Ages 50+
ADARx Pharmaceuticals, Inc. · Sites in Canada, United States, Australia and 9 more countries
Ages 60+
ONL Therapeutics · Sites in Canada, United States, Austria and 9 more countries
Ages 55+
Kriya Therapeutics, Inc. · Sites in Canada, United States, Israel and 1 more country
Ages 55–80
Regeneron Pharmaceuticals · Sites in Canada, United States, Australia and 8 more countries
Ages 50–85
A study can be open while its sites in Canada have not opened yet or have stopped. Only those recruiting at a site in Canada →
Of the 40 Geographic Atrophy studies recruiting now, 31 (78%) set no upper age limit and none (0%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.
This study: 50 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
22 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 8 · Phase 3 11
First in 2011; this study’s year is marked. 4 started in 2024.
This study's enrollment of 42 is below the median of 130 across 39 observational studies indexed under Geographic Atrophy.
Median enrollment 390 across the 18 interventional studies, 146 across the 4 observational. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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21 of 22 have an industry lead sponsor. The 10 most frequent:
Optina Diagnostics Inc. is the lead sponsor of 10 studies on the registry; none are open to participants now.
Optina Diagnostics Inc. has 1 study filed under Geographic Atrophy — fewer than ten, so there is no comparison to draw.
1 of the studies in Geographic Atrophy with a site in Canada that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06510816Phase 3Annexon, Inc.A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) | 2027-07-31 |
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Among the 22 studies in Geographic Atrophy with a site in Canada, from their registry updates:
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This study used a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.
This retrospective, case-control study used the clinical data previously collected by Optina (CIP 22-003 AND Study, CIP 22-004 CAS Training Study and RWD 24-011 RWD Study). As such, no new participants were enrolled for this study. The review and annotation of the MHRC H5 Images for GA are within the scope of each of these studies and the study participants have provided their Informed Consent for use of their retinal scans to assess clinical diagnostic applications. Images from the above-mentioned studies that met the inclusion criteria (there were no exclusion criteria) were classified into 3 different cohorts per the selection process described in the Study Protocol. Each cohort required a minimum of 10 MHRC Images from unique eyes with matched OCT scans.
Cohort A: Eyes of patients with a diagnosis of dry AMD with GA lesions:
o This cohort included patients with intermediate-or late-stage dry AMD where GA lesions are present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
Cohort B: Eyes of patients with diagnosis of dry AMD without the presence of GA lesions
o This cohort included patients with early or intermediate dry AMD where GA lesions are not present, based on either the diagnostic information provided by the clinic, or by visible assessment of either the HSI or OCT images performed by the Optina Analyst.
Cohort C: Eyes of age-matched healthy patients (no AMD or GA lesions)
CapeStart Study Personnel were trained in using Optivizon Viewing Software, the viewing software included in the marketed version of Optina-4C (MHRC device), and the Optina Segmentation tool.
Additionally, they were trained in the presentation of GA in HSI Images. Evaluation Phase CapeStart were provided with the Test Dataset of eye scans (n=40 eyes). CapeStart Optometristsreviewed all the HSI Images from the Optina-4C in Optivizon, annotated any GA lesions (if present) in the RelSpec@560 image using the Optina Segmentation tool, and completed the HSI Questionnaire for the MHRC H5 Images. Annotation Process The HSI RelSpec@560 Images were annotated by the CapeStart Optometrists for the Evaluation Phase.
The annotations were completed using the validated Optina Segmentation Tool per the User Manual, and all image annotations were performed on the Virtual Machine established and validated by Optina for this study.
If the eye was considered to have at least one GA lesion after viewing the MHRC H5 Images in Optivizon, the RelSpec@560 Image was annotated using the Optina Segmentation Tool. The annotator used the yellow label for high confidence level for GA visualization and Blue label for low confidence level.
Reference Data The IOI was responsible for generating the reference data. The IOI reviewed all OCT images as well as the MHRC H5 Images, then annotated the RelSpec@560 images. The IOI visual assessment made note of all cRORA (GA lesions) and iRORA (nascent GA lesion) in the OCT and aligned where possible with corresponding lesions in the HSI images. Lastly, the IOI completed the HSI Questionnaire for all annotated Relspec images.
This study will use a retrospective dataset collected by Optina under different study protocols. The target study population will include adults over the age of 50 years, with and without the presence of AMD.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants may enter the study only if ALL the following inclusion criteria are present:
Exclusion Criteria:
Eyes of patients with a diagnosis of dry AMD with GA lesions
Other: Retrospective Study
Eyes of patients with a diagnosis of AMD without the presence of RPE disruptions
Other: Retrospective Study
Eyes of age-matched healthy patients (no AMD or GA lesions)
Other: Retrospective Study
Retrospective Study This study will use a retrospective Test Dataset of eye scans collected by Optina under different study protocols. MHRC H5 Images collected as part of Optina studies CIP-22-003, CIP-22-004, DOC100463 or RWD-24-011 will be reviewed by an Optina Data Analyst and flagged for potential match to the Target Population. Of the flagged images, 40 will be selected and allocated to the Test Dataset. All selected images must have a matching OCT image for review as part of the Reference Data. The Test Dataset will be documented in the CIP-24-015 data spreadsheet and archived in the CIP-24-015 central files.
Comparison of the total number of Relspec images annotated for GA lesions
Comparison of the total number of Relspec images annotated for GA lesions of at least 29 pixels or larger with the total number of OCT images with identified GA lesions (cRORA) in the Test Dataset.
Time frame: 45 days
Comparison of the total number of 'high certainty' GA lesions
Comparison of the total number of 'high certainty' GA lesions (Yellow label) of at least 29 pixels annotated in all Relspec images with the total number of (cRORA) identified in the OCT images in the Test Dataset.
Time frame: 45 days
Comparison of the total number of GA lesions
Comparison of the total number of GA lesions (Yellow label and Dark Blue label) of at least 29 pixels or larger annotated in all Relspec images with the total number of identified GA lesions (cRORA) in the OCT images in the Test Dataset.
Time frame: 45 days
Evaluation of the Global DICE Score
Evaluation of the Global DICE Score for annotations of 29 pixels or larger performed by CapeStart compared with the Reference Data.
Time frame: 45 days
Ran from Dec 2024 to primary completion in Feb 2025, 1 month.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Optina Diagnostics Inc.