Retinal DiseasesCENTAURUSNCT04968756
Evaluating the Safety of the SPECTRALIS CENTAURUS Device
A study testing Selective retina therapy SPECTRALIS CENTAURUS device in people with Retinal Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Retinal Diseases
- What is being tested?
- Selective retina therapy SPECTRALIS CENTAURUS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- 9 Sep 2021to Dec 2025
- Phase
- Interventional
- 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 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written Informed Consent
- For Stage 1, any patient aged >18 years with the need for conventional laser retina ablation
- For Stage 2, will be restricted to people aged 50 to <95 years with lesion characteristics that meet the criteria for intermediate AMD
Who cannot join
- Presence of reticular pseudodrusen
- Any manifestation of late-stage AMD
- Known hypersensitivity or allergy to fluorescein or uncontrolled hypertension
- Concomitant systemic corticosteroid treatment for continuous period longer than 2 weeks
- History of any vitreous haemorrhage within 4 weeks prior to screening or current haemorrhage in the study eye
- Inability to obtain fundus photographs or fluorescein angiogram of sufficient quality
Show all 13Show fewer
- Photosensitive epilepsy
- Insufficient retinal pigmentation (albinism)
- Corneal opacity / lens opacity
- Women of child-bearing potential
- Contralateral eye is at an advanced stage of disease and has poor visual acuity
- Inability to follow the procedures of the study
- Participation in another study with investigational drug within the 30 days preceding and during the present study - Inability or lack of willingness to commit to return for all clinical visits and complete all study-related procedures
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Inselspital
Bern, 3010
Chantal Dysli, PhD Dr. med.
About this study
Official title: Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography
The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases.
Read the detailed description
Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The SPECTRALIS CENTAURUS device implements optical coherence tomography (OCT) to detect intentional elimination of RPE cells caused by a prototype laser for selective retina therapy (SRT).
Within this clinical trial the safety of the SPECTRALIS CENTAURUS device and its ability to detect RPE cell damage towards selective real-time laser microsurgery will be evaluated.
- Conditions
- Retinal Diseases
- Being tested
- Selective retina therapy SPECTRALIS CENTAURUS device
- Keywords
- Retinal Pigment Epithelium
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selective retina therapy SPECTRALIS CENTAURUS deviceDevice
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the SPECTRALIS CENTAURUS device | Experimental | In Stage 1, two laser pattern will be applied in areas of the retina that require ablative laser photocoagulation.
In Stage 2, a laser pattern will be applied along and on the outside of the arcades. Furthermore, a treatment pattern will be applied to an area temporal to the fovea affected by intermediary age-related macular degeneration (AMD) and confluent soft drusen. Receives: Device: Selective retina therapy SPECTRALIS CENTAURUS device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety SPECTRALIS CENTAURUS - AEs
The primary objective of this study is to assess the safety of the SPECTRALIS CENTAURUS device in clinical use by the evaluation of any adverse events (AEs) that may be related to the study device or the study intervention, including device deficiencies (DDs)
The following potential AEs are evaluated throughout the study regarding the laser treatment:
- Decrease in visual acuity
- Choroidal neovascularization at treatment location (laser lesion)
- Transient increased edema / decreased vision
- Development or worsening of macular edema
- Bruch's membrane rupture
- Retinal and choroidal haemorrhage
- Inadvertent foveal burns
Measured: 26 weeks
Safety SPECTRALIS CENTAURUS - DDs
In addition to the AEs, the following potential device deficiencies (DDs) can be listed in relation to the treatment and the SPECTRALIS CENTAURUS device:
- Unintentional laser delivery
- Unintentional OCT (M-scan) failure during the treatment
- Unintentional scanning laser ophthalmoscope (SLO) failure during the treatment
- Unintentional treatment software failure during the treatment
- Unintentional treatment laser failure during the treatment
- Basic system failure during the treatment
Beside the DDs mentioned above, additional sub-criteria are assessed by default in advance to the treatment visit according to an acceptance test protocol (ATP). The ATP establishes the acceptance test framework for the SPECTRALIS CENTAURUS and describes the scope of the work performed and the approach taken to validate that the system performs as required. An acceptance test is carried out on each day on which a patient is to be treated.
Measured: At treatment (baseline)
Secondary outcomes (5)
Evaluation of OCT for SRT dosimetry
During treatment, OCT M-scans are recorded collinear to the treatment laser application. Post-treatment, all lesions are examined by fluorescein angiography (FA) for RPE cell damage. In addition, the OCT-M scan data is examined for fringe washouts (signal washouts) that occur with RPE cell damage. An analysis of these data (RPE cell damage vs. OCT fringe washouts) will reveal whether OCT is suitable for real-time dosimetry of SRT.
Measured: At treatment (baseline)
Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)
Course of disease monitoring on AMD and confluent soft drusen with BCVA: Visual acuity is assessed using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart (consisting of rows of letters) / LogMAR chart (Logarithm of the Minimum Angle of Resolution), after appropriate refraction. Visual acuity represents the basic and most clinically relevant functional test to evaluate of central visual acuity.
Measured: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to OCT imaging
Course of disease monitoring on intermediary AMD and confluent soft drusen with OCT: OCT provides non-invasive morphological assessment of the retinal layers including the RPE and the choroid. It is a commonly used objective method during clinical assessment. OCT allows to identify structural changes such as Bruch's membrane ruptures, choroidal neovascularizations (CNV) with exudative macular edema, photoreceptor damage and drusen evolution. A macular volume OCT scan centered at the fovea will be acquired routinely. Additionally, volume OCT scans across the laser area will be acquired. This allows, for example, that a change in retinal thickness (μm) can be observed in the short term as well as in the long term. No single endpoint is given for this examination. However, experience shows that CNV would be the most likely case which can be expected with this laser treatment.
Measured: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to FA imaging
Course of disease monitoring on intermediary AMD and confluent soft drusen with FA: Fluorescein is injected intravenously before serial fundus image are taken after excitation of the fluorescein dye. No single endpoint is given for this examination. However, experience shows that CNV and subtle laser scars would be the most likely cases which can be expected with this laser treatment.
Measured: At treatment (baseline) and after 12 weeks
Progression of AMD after laser treatment according to color fundus photography (CFP)
Course of disease monitoring on intermediary AMD and confluent soft drusen with CFP: CFP will be used to document and monitor pigmentary changes of the fundus and potential formation of scars after laser application. Since it is difficult to quantify fundus image changes, the principal investigator as well as a safety committee will evaluate fundus changes on an individual basis, taking into account the location and laser parameters used in the participant.
Measured: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start9 Sep 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseasesStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Responsible party
- Sponsor
- Investigators
- Chantal Dysli, MD PhD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968756
- Sponsor's protocol ID
- CENTAURUS
- Acronym
- CENTAURUS
- Status last verified
- Jan 2024
- First submitted
- 26 Apr 2021
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography
- ClinicalTrials.gov ID
- NCT04968756
- Acronym / sponsor ID
- CENTAURUS / CENTAURUS
- Conditions
- Retinal Diseases
- Keywords
- Retinal Pigment Epithelium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Bern University of Applied Sciences
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jul 2021 (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.
The objective of this clinical trial is to evaluate the safety of the SPECTRALIS CENTAURUS device (HuCE-optoLab, BFH TI, Biel, CH) in a clinical setting on patients with retinal diseases.
Detailed description
Optical microsurgery of the retinal pigment epithelium (RPE) requires reliable real-time dosimetry to prevent unwanted overexposure of the neuroretina. The SPECTRALIS CENTAURUS device implements optical coherence tomography (OCT) to detect intentional elimination of RPE cells caused by a prototype laser for selective retina therapy (SRT).
Within this clinical trial the safety of the SPECTRALIS CENTAURUS device and its ability to detect RPE cell damage towards selective real-time laser microsurgery will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with the SPECTRALIS CENTAURUS device | Experimental | Device: Selective retina therapy SPECTRALIS CENTAURUS deviceIn Stage 1, two laser pattern will be applied in areas of the retina that require ablative laser photocoagulation. In Stage 2, a laser pattern will be applied along and on the outside of the arcades. Furthermore, a treatment pattern will be applied to an area temporal to the fovea affected by intermediary age-related macular degeneration (AMD) and confluent soft drusen. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Written Informed Consent
- For Stage 1, any patient aged >18 years with the need for conventional laser retina ablation
- For Stage 2, will be restricted to people aged 50 to <95 years with lesion characteristics that meet the criteria for intermediate AMD
Key exclusion criteria (13 listed)
- Presence of reticular pseudodrusen
- Any manifestation of late-stage AMD
- Known hypersensitivity or allergy to fluorescein or uncontrolled hypertension
- Concomitant systemic corticosteroid treatment for continuous period longer than 2 weeks
- History of any vitreous haemorrhage within 4 weeks prior to screening or current haemorrhage in the study eye
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 |
|---|---|---|
| Selective retina therapy SPECTRALIS CENTAURUS deviceMicrosecond laser microsurgery by using the SPECTRALIS CENTAURUS device | Device | Treatment with the SPECTRALIS CENTAURUS device |
Primary outcome
Safety SPECTRALIS CENTAURUS - AEs
Time frame: 26 weeks
The primary objective of this study is to assess the safety of the SPECTRALIS CENTAURUS device in clinical use by the evaluation of any adverse events (AEs) that may be related to the study device or the study intervention, including device deficiencies (DDs) The following potential AEs are evaluated throughout the study regarding the laser treatment: * Decrease in visual acuity * Choroidal neovascularization at treatment location (laser lesion) * Transient increased edema / decreased vision * Development or worsening of macular edema * Bruch's membrane rupture * Retinal and choroidal haemorrhage * Inadvertent foveal burns
Safety SPECTRALIS CENTAURUS - DDs
Time frame: At treatment (baseline)
In addition to the AEs, the following potential device deficiencies (DDs) can be listed in relation to the treatment and the SPECTRALIS CENTAURUS device: * Unintentional laser delivery * Unintentional OCT (M-scan) failure during the treatment * Unintentional scanning laser ophthalmoscope (SLO) failure during the treatment * Unintentional treatment software failure during the treatment * Unintentional treatment laser failure during the treatment * Basic system failure during the treatment Beside the DDs mentioned above, additional sub-criteria are assessed by default in advance to the treatment visit according to an acceptance test protocol (ATP). The ATP establishes the acceptance test framework for the SPECTRALIS CENTAURUS and describes the scope of the work performed and the approach taken to validate that the system performs as required. An acceptance test is carried out on each day on which a patient is to be treated.
5 secondary outcomes
Evaluation of OCT for SRT dosimetry
Time frame: At treatment (baseline)
Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to OCT imaging
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Progression of AMD after laser treatment according to FA imaging
Time frame: At treatment (baseline) and after 12 weeks
Progression of AMD after laser treatment according to color fundus photography (CFP)
Time frame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Chantal Dysli, MD PhD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selective retina therapy SPECTRALIS CENTAURUS device in people with Retinal Diseases, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 3 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 11 Jan 2024. 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 Switzerland. 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 Martin Zinkernagel, MD PhD (+41 (0)31 632 85 03, martin.zinkernagel@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety SPECTRALIS CENTAURUS - AEs (time frame: 26 weeks). The study lists 2 primary outcomes in all. 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 11 Jan 2024.