Back to resultsEvaluating the Safety of the SPECTRALIS CENTAURUS Device (CENTAURUS)
Primary Purpose
Retinal Diseases
Status
Recruiting
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Selective retina therapy SPECTRALIS CENTAURUS device
Sponsored by
About this trial
This is an interventional treatment trial for Retinal Diseases focused on measuring Retinal Pigment Epithelium
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- University Hospital InselspitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment with the SPECTRALIS CENTAURUS device
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT04968756
First Posted
April 26, 2021
Last Updated
May 11, 2023
Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bern University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04968756
Brief Title
Evaluating the Safety of the SPECTRALIS CENTAURUS Device
Acronym
CENTAURUS
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2021 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Insel Gruppe AG, University Hospital Bern
Collaborators
Bern University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retinal Diseases
Keywords
Retinal Pigment Epithelium
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with the SPECTRALIS CENTAURUS device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Selective retina therapy SPECTRALIS CENTAURUS device
Intervention Description
Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
Primary Outcome Measure Information:
Title
Safety SPECTRALIS CENTAURUS - AEs
Description
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
Time Frame
26 weeks
Title
Safety SPECTRALIS CENTAURUS - DDs
Description
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.
Time Frame
At treatment (baseline)
Secondary Outcome Measure Information:
Title
Evaluation of OCT for SRT dosimetry
Description
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.
Time Frame
At treatment (baseline)
Title
Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)
Description
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.
Time Frame
At treatment (baseline) and after 1, 4, 12 and 26 weeks
Title
Progression of AMD after laser treatment according to OCT imaging
Description
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.
Time Frame
At treatment (baseline) and after 1, 4, 12 and 26 weeks
Title
Progression of AMD after laser treatment according to FA imaging
Description
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.
Time Frame
At treatment (baseline) and after 12 weeks
Title
Progression of AMD after laser treatment according to color fundus photography (CFP)
Description
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.
Time Frame
At treatment (baseline) and after 1, 4, 12 and 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Wolf, MD PhD
Phone
+41 (0)31 632 85 03
Email
sebastian.wolf@insel.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Chantal Dysli, MD PhD
Phone
+41 (0)31 632 25 01
Email
chantal.dysli@insel.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chantal Dysli, MD PhD
Organizational Affiliation
University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chantal Dysli, PhD Dr. med.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluating the Safety of the SPECTRALIS CENTAURUS Device
We'll reach out to this number within 24 hrs