Clinical trial NCT04968756: Evaluating the Safety of the SPECTRALIS CENTAURUS Device
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
Overall status: RECRUITING
Phase: NA
Conditions: Retinal Diseases
Keywords: Retinal Pigment Epithelium
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Bern University of Applied Sciences
First posted: 2021-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Safety SPECTRALIS CENTAURUS - AEs
timeFrame: 26 weeks
measure: Safety SPECTRALIS CENTAURUS - DDs
timeFrame: At treatment (baseline)
Secondary outcomes:
measure: Evaluation of OCT for SRT dosimetry
timeFrame: At treatment (baseline)
measure: Progression of AMD after laser treatment according to best-corrected visual acuity (BCVA)
timeFrame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
measure: Progression of AMD after laser treatment according to OCT imaging
timeFrame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
measure: Progression of AMD after laser treatment according to FA imaging
timeFrame: At treatment (baseline) and after 12 weeks
measure: Progression of AMD after laser treatment according to color fundus photography (CFP)
timeFrame: At treatment (baseline) and after 1, 4, 12 and 26 weeks
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Inselspital
Study officials:
affiliation: University of Bern
name: Chantal Dysli, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: