Evaluating the Safety of the SPECTRALIS CENTAURUS Device

NCT04968756 | Unknown DMC

• 1 other identifier: CENTAURUS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Retinal Diseases

Keywords

Retinal Pigment Epithelium

Outcome Measures

Primary Outcomes (2)

• 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

  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.

  At treatment (baseline)

Secondary Outcomes (5)

• Evaluation of OCT for SRT dosimetry

  At treatment (baseline)

• Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)

  At treatment (baseline) and after 1, 4, 12 and 26 weeks

• Progression of AMD after laser treatment according to OCT imaging

  At treatment (baseline) and after 1, 4, 12 and 26 weeks

• Progression of AMD after laser treatment according to FA imaging

  At treatment (baseline) and after 12 weeks

• Progression of AMD after laser treatment according to color fundus photography (CFP)

  At treatment (baseline) and after 1, 4, 12 and 26 weeks

Study Arms (1)

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.

Device: Selective retina therapy SPECTRALIS CENTAURUS device

Interventions

Selective retina therapy SPECTRALIS CENTAURUS device DEVICE

Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device

Treatment with the SPECTRALIS CENTAURUS device

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Bern University of Applied Sciences: collaborator

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Retinal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Chantal Dysli, MD PhD

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martin Zinkernagel, MD PhD

CONTACT

+41 (0)31 632 85 03; martin.zinkernagel@insel.ch

Chantal Dysli, MD PhD

CONTACT

+41 (0)31 632 25 01; chantal.dysli@insel.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: July 20, 2021
• Study Start: September 9, 2021
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)