H35.31
Conditions
Interventions
Group 1: Continuation of the treatments of the MacuTherm-Dosing-Trial quarterly at a high-dose over a 2 year period.
Group 2: Continuation of the treatments of the MacuTherm-Dosing-Trial quarterly at
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinically confirmed early as well as advanced intermediate AMD with the presence of soft drusen, reticular pseudodrusen, or a mixed form of both; furthermore, in the context of advanced intermediate AMD, hyperreflective foci (HRF), alterations of the ellipsoid zone (EZ), and drusen and RPE migration - Best-corrected visual acuity between 1.0 and 0.5 (decimal, ETDRS chart) - Clear optical media - Ability to communicate clearly and to understand and comply with the nature and requirements of the study - Ability to provide written informed consent in accordance with institutional, local, and national regulatory guidelines and to attend all study visits - Completed participation in the MacuTherm Dosing Study
Exclusion criteria
Exclusion criteria: Presence of advanced AMD, including neovascular AMD (nAMD) or geographic atrophy (GA), or RPE migration (pre-GA) in the treated eye; incomplete macular atrophy - Maculopathies presenting with pseudodrusen only - Any significant deterioration of optical media or media opacities, including corneal opacities, cataract formation (with anticipated need for cataract surgery within 12 months), and vitreous hemorrhage, which could impair visualization of target structures in the study eye(s) by the laser surgeon - Glaucoma (advanced or untreated) - Any other ocular disease that may progress during the study period and confound the assessment of visual acuity (e.g., diabetic macular edema, active vitreoretinal disease, intraocular tumor, retinal vascular disease), except for the study disease - Uveitis - Any ophthalmic or systemic medications known to be toxic to the lens, retina, or optic nerve - Any intraocular surgery in a qualifying eye within three months prior to study inclusion - History of vitrectomy, filtering surgery, corneal transplantation, or retinal detachment - Prior therapeutic radiation to the ocular region of either eye - Neurological diseases that may affect the results of electrophysiological measurements (especially mfERG) - Women participating in the study are, at an age >55 years, unlikely to be of childbearing potential - Participation in a study involving investigational drugs, biologics, or devices within 6 months prior to study start (Note: Clinical observational studies involving only over-the-counter vitamins, dietary supplements, or diets are not excluded) - Any severe medical condition that prevents the subject from performing study activities (including cardiac, hepatic, renal, respiratory, endocrine, neurological, or hematological diseases), or that, in the investigator’s judgment, is likely to require surgical intervention or hospitalization at any time during the study - If, in the opinion of the investigator, adherence to the study protocol is unlikely
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the conversion rate of early or advanced intermediate AMD to one of the two late-stage forms (the exudative form or geographic atrophy). This criterion is assessed based on OCT imaging. Data are collected on a quarterly basis. The endpoint is considered reached if, after 12 months (i.e., a total of 24 months after the start of the preceding dosing study), there is a significant difference between the groups in the conversion from intermediate AMD to a late-stage form of AMD. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measurement of anatomical changes in the treated area using SD-OCT (spectral-domain optical coherence tomography) - Detection and longitudinal follow-up of changes in various OCT biomarkers (drusen, ellipsoid zone, hypertransmission defects) - Changes in OCT-BAF images in the treated area - Changes in choriocapillaris perfusion density in the treated area assessed by OCT angiography (OCT-A) - Subgroup analysis for patients with reticular pseudodrusen (RPD) versus soft drusen (SD) - Amsler grid analysis - Change in retinal sensitivity as measured by MAIA microperimetry - Change in ETDRS best-corrected visual acuity (BCVA) - Change in contrast sensitivity (LCVA, FrACT) - Change in visual acuity under low luminance conditions (LLVA, FrACT) - Change in NEI VFQ-25 questionnaire score | — |
Countries
Germany
Contacts
Public ContactJan Tode
Medizinische Hochschule Hannover
Outcome results
None listed