Evaluating the safety of a new device for retinal diseases
Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography
This study is testing a new device to see if it can safely help doctors monitor and treat retinal diseases during laser surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Insel Gruppe AG, University Hospital Bern Academic / other |
| Locations | 1 site (Bern) |
| Trial ID | NCT04968756 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety of the SPECTRALIS CENTAURUS device, which utilizes optical coherence tomography (OCT) to monitor real-time dosimetry during selective retina therapy. The study will involve patients with retinal diseases, specifically focusing on the detection of retinal pigment epithelium (RPE) cell damage during laser microsurgery. Participants will be evaluated for their eligibility based on specific age and health criteria, and the trial will be conducted at the University Hospital Inselspital in Bern.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years needing conventional laser retina ablation, particularly those aged 50 to 95 with intermediate age-related macular degeneration (AMD).
Not a fit: Patients with advanced stages of AMD or specific ocular conditions such as reticular pseudodrusen will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the safety and effectiveness of laser treatments for retinal diseases.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving laser treatment safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bern
- University Hospital Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Chantal Dysli, MD PhD — University of Bern
- Study coordinator: Martin Zinkernagel, MD PhD
- Email: martin.zinkernagel@insel.ch
- Phone: +41 (0)31 632 85 03
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.