Retinitis PigmentosaIHRNCT04128150
High Resolution Retina Imaging
An observational study of Retinitis Pigmentosa and Maculopathy, Age Related, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 3 sites in France.
Trial summary
To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy
- How many people
- 1,000 participants
- Where
- 3 sitesFrance
- Study dates
- 17 Jan 2018to 30 Jan 2024
- How long will I take part?
- 5 Years
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with pathologies affecting photoreceptors and the retinal vessels
Who may be able to join
- Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
- Beneficiaries of the health insurance
Who cannot join
- Any abnormality preventing good quality OA imaging on both eyes
- Major under guardianship or curatorship
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Hôpital Lariboisière
Paris, 75010
Valérie Krivosic, PH
- Recruiting
Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
Paris, 75012
Michel PAQUES, PU-PH, 01 40 02 14 15, mpaques@15-20.fr
- Not yet recruiting
Hôpital Pitié-Salpétrière
Paris, 75013
Antonio Gallo, PH
About this study
To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Degeneration, Diabetic Retinopathy
- Medical subject headings
- Retinitis Pigmentosa, Macular Degeneration, Macular Edema, Retinal Degeneration, Diabetic Retinopathy, Retinal Vein Occlusion, Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of retina diseases
Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact
Measured: From date of inclusion until the date of last documented progression , assessed up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start17 Jan 2018
- Primary completion30 Jan 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel PAQUES, Principal investigator, Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128150
- Sponsor's protocol ID
- 2017-A03223-50
- Other IDs
- 2017-A03223-50
- Acronym
- IHR
- Status last verified
- Oct 2019
- First submitted
- 14 Oct 2019
- Last updated
- 16 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.
PubMed 35814763
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Resolution Retina Imaging
- ClinicalTrials.gov ID
- NCT04128150
- Acronym / sponsor ID
- IHR / 2017-A03223-50
- Conditions
- Retinitis Pigmentosa, Maculopathy, Age Related, Macular Dystrophy, Macular Edema, Retinal Degeneration, Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Centre Hospitalier National d'Ophtalmologie des Quinze-VingtsUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 30 Jan 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 16 Oct 2019 (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.
To increase the clinical experience of using the rtx1 camera in various retinal disorders and to follow the evolution of structural alterations during retinal diseases using adaptive optics imaging with the rtx1 camera
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with pathologies affecting photoreceptors and the retinal vessels
Key inclusion criteria (2 listed)
- Persons over 12 years of age, of both sexes, presenting with retinal pathologies.
- Beneficiaries of the health insurance
Key exclusion criteria (2 listed)
- Any abnormality preventing good quality OA imaging on both eyes
- Major under guardianship or curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of retina diseases
Time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years
Increase the clinical experience of using the rtx1 camera in various conditions with retinal impact
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2019.
- Derived from this study: PubMed 35814763Paques M, Norberg N, Chaumette C, Sennlaub F, Rossi E, Borella Y, Grieve K. Long Term Time-Lapse Imaging of Geographic Atrophy: A Pilot Study. Front Med (Lausanne). 2022 Jun 22;9:868163. doi: 10.3389/fmed.2022.868163. eCollection 2022.
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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.
Michel PAQUES principal investigator
Centre Hospitalier National d'Ophtalmologie des Quinze-Vints
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinitis Pigmentosa and Maculopathy, Age Related, run by Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts at 3 sites in France.
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 2 inclusion and 2 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 16 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 Tania RILCY (+33 140021126, trilcy@15-20.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of retina diseases (time frame: From date of inclusion until the date of last documented progression , assessed up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04128150, which also lists 1 linked publication.
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 16 Oct 2019.