AMD - Age-Related Macular DegenerationNCT06846151
Retinal Investigation Using Optos OCT Device
A study testing retinal functional imaging in people with AMD - Age-Related Macular Degeneration and Retinitis Pigmentosa (RP), run by Optos, PLC.
Trial summary
Retinal investigation using OCT with control and diseased eyes Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- AMD - Age-Related Macular Degeneration, Retinitis Pigmentosa (RP), Diabetic Retinopathy
- What is being tested?
- retinal functional imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
- Participants who understand the study and patient information sheet and can follow the instructions.
- Participants who agree to participate in the study.
- Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
- Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases
Who cannot join
- Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent
- Ophthalmic disease other than condition under investigation.
- Participants unable to tolerate ophthalmic imaging.
- Cataract (unless deemed mild in the opinion of the investigator)
- Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.
- Diabetes (unless part of the diabetic eye disease group)
Show all 11Show fewer
- Binocular visual acuity worse than 6/18
- Strabismus (squint)
- Age related macular degeneration groups: polypoidal choroidal vasculopathy
- Participants with photo sensitivity epilepsy, experience of seizures, or sensitivity to flickering light (based on self-report)
- Pregnant
About this study
Official title: Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
Retinal investigation using OCT with control and diseased eyes
- Conditions
- AMD - Age-Related Macular Degeneration, Retinitis Pigmentosa (RP), Diabetic Retinopathy, Control Patients
- Being tested
- retinal functional imaging
- Medical subject headings
- Macular Degeneration, Retinitis Pigmentosa, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinal functional imagingDevice
Also called OCT
this is a proof of concept study
| Study group | Role | What they receive |
|---|---|---|
| standard imaging process | Other | All participants will undergo the same imaging Receives: Device: retinal functional imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
OCT physical response data
Response data per participant will be collected and analyzed
Measured: 6 months from recruitment start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMD - Age-Related Macular DegenerationStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- all participants receive a single intervention at a single point in time
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Optos, PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06846151
- Sponsor's protocol ID
- OPT1105
- Other IDs
- REC ref: 25/NS/0018, IRAS Project ID: 338297
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Optos OCT in Patients with Retinal Pathologies
- ClinicalTrials.gov ID
- NCT06846151
- Acronym / sponsor ID
- OPT1105
- Conditions
- AMD - Age-Related Macular Degeneration, Retinitis Pigmentosa (RP), Diabetic Retinopathy, Control Patients
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Optos, PLCIndustry (pharma, biotech, devices)
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 25 Feb 2025 (actual)
- 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.
Retinal investigation using OCT with control and diseased eyes
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- all participants receive a single intervention at a single point in time
| Arm | Type | Receives |
|---|---|---|
| standard imaging process | Other | Device: retinal functional imagingAll participants will undergo the same imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female participants 18 years of age or older who have full legal capacity to volunteer on the date the informed consent is signed.
- Participants who understand the study and patient information sheet and can follow the instructions.
- Participants who agree to participate in the study.
- Control group where no retinal abnormalities were detected as part of the standard basic ophthalmic examination.
- Participants with retinal disease in at least one eye including: Early dry age-related macular degeneration, late stage dry age-related macular degeneration specifically geographic atrophy, Wet age-related macular degeneration, Retinitis pigmentosa, Diabetic retinopathy and other macular atrophic diseases
Key exclusion criteria (11 listed)
- Inability to understand written and verbal English sufficiently to comprehend the study and provide informed consent
- Ophthalmic disease other than condition under investigation.
- Participants unable to tolerate ophthalmic imaging.
- Cataract (unless deemed mild in the opinion of the investigator)
- Participants with significant ocular media not sufficiently clear to obtain acceptable OCT images.
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 |
|---|---|---|
| retinal functional imagingAlso: OCTthis is a proof of concept study | Device | standard imaging process |
Primary outcome
OCT physical response data
Time frame: 6 months from recruitment start
Response data per participant will be collected and analyzed
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing retinal functional imaging in people with AMD - Age-Related Macular Degeneration and Retinitis Pigmentosa (RP), run by Optos, PLC.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OCT physical response data (time frame: 6 months from recruitment start). 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 25 Feb 2025.