Evaluating the Safety of the SPECTRALIS CENTAURUS Device

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Jul 8, 2021

Keywords

ClinConnect Summary

This clinical trial is focused on evaluating the safety of a new device called the SPECTRALIS CENTAURUS, which is designed to treat patients with retinal diseases. The study aims to see how well this device works in a real-world clinical setting. If you or someone you know has retinal issues and is interested in participating, the trial is currently looking for people aged 18 and older who need laser treatment for their condition. However, for a specific part of the study, participants need to be between 50 and 95 years old and meet certain criteria related to a condition called intermediate age-related macular degeneration (AMD).

Participants in the trial will need to provide written consent and attend several clinical visits to follow the study's procedures. It's important to note that some individuals may not be eligible due to specific health conditions or treatments they may be undergoing, such as certain eye diseases or medications. Overall, this trial represents an opportunity to contribute to the understanding of new treatments for retinal diseases while receiving care for your condition.

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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