MacuTherm Performance Study in Patients With iAMD

Exclusion Criteria

• •Presence of late-stage AMD, neovascular (nAMD, active or fibrotic) or geographic atrophy (GA)
• •Maculopathies showing only pseudodrusen
• •Any systemic medication known to be toxic to the lens, retina or optic nerve
• •Any intraocular surgery within 6 months prior to study inclusion (except uncomplicated cataract surgery \> 3 months)
• •Any previous thermal laser treatment in the macula
• •History of vitrectomy, filter surgery, corneal transplantation or retinal detachment
• •Previous therapeutic radiotherapy in the eye region
• •Pregnant or breast-feeding patients
• •Participation in an investigational drug, biologic or device study within 6 months prior to study entry (Note: observational clinical studies involving only over-the-counter vitamins, supplements or diets are not excluded)
• •Expected participation in an investigational drug, biologic or device study during the duration of this clinical investigation except clinical investigations for diagnostic purposes where examinations are not influencing the outcome of the current clinical investigation. Mandatory for participation in this additional clinical investigation is prior approval from the sponsor of this clinical investigation in writing
• •A serious medical condition that prevents the patient from performing study activities (including cardiac, hepatic, renal, respiratory, endocrinological, neurological or haematological conditions) or, in the opinion of the investigator, is likely to require surgery or hospitalization (at any time during his/her participation on this clinical investigation)
• •Known allergy to any ingredient required (for dilation of the pupil, if no alternative agent may be applied) or any contraindication to be treated with Navilas® Laser System 577SL
• •If, in the opinion of the investigator, it is unlikely that the study protocol will be followed
• •If only one eye is eligible for inclusion, none of the following criteria must be present in the fellow eye in order to allow inclusion of the study eye:
• •Presence of late-stage AMD in need of therapy
• •Presence of neovascular AMD (nAMD) in need of therapy
• •Presence of geographic atrophy (GA) in need of therapy (e.g. complement-inhibitors)
• •Previous therapeutic radiotherapy in the fellow eye region