Evaluating the Safety of the SPECTRALIS CENTAURUS Device

Open Label Early Feasibility Study Evaluating the Safety of the SPECTRALIS CENTAURUS Device for Dosimetry of Selective Retina Therapy With Optical Coherence Tomography

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.

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.

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