Age-related Macular Degeneration (AMD)
Conditions
Interventions
Group 1: full-dose treatment
The treatment is a non-damaging laser treatment of the eye. It is a non-contact treatment. The laser makes an image of the posterior eye and then thermally stimulates the
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
55 Years to 85 Years
Inclusion criteria
Inclusion criteria: • clinically diagnosed early or intermediate AMD with soft drusen, reticular pseudodrusen or both • BCVA between 20/25 and 20/200 • clear optical media • ability to communicate and understand the essence of the study • ability to give written consent
Exclusion criteria
Exclusion criteria: • advanced AMD, neovascular AMD, geographic atrophy or intraretinal hyperreflective foci (migrating-RPE) in the treated eye, incomplete outer retinal atrophy (iRORA) • any prior treatment, except for antioxidants, vitamins or other supplements • opacity of optic media like Cataract, corneal haze, vitreous haze and the need for cataract-surgery within the next 12 months on physicians descretion • glaucoma (advanced or untreated) • any other eye disease that may advance during the trial and lead to vision loss • uveitis • any medication known to be toxic to the eye • operations to the eye up to three months prior to the study • any prior thermal laser therapy to the macula • vitrectomy, filter operation, corneal transplantation retinal detachment in medical history • therapeutic irradiation of the eye prior to the study • neurological diseases that might impair functional and electrophysiological results • pregnancy should not affect the included women, since age is above 55. • participation in other clinical trial within the trial or 6 months prior • severe medical condition making the trial impossible • upon physicians judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual function assessment: low contrast visual acuity (LCVA) and low luminance visual acuity (LLVA) All endpoints will be carried out at baseline, monthly for the first 3 months and then quarterly until the end of the first year. | — |
Secondary
| Measure | Time frame |
|---|---|
| • change in anatomical structures of the retina by SD-OCT (spectral domain optical coherence tomography) and adaptive optics and high-resolution OCT • rate of progression to late stage AMD (geographic atrophy, neovascular AMD) • changes in OCT biomarkers • change in autofluorescence • perfusion of choriocappillaris • subgroup analysis for retinal pseudodrusen (RPD) versus soft drusen (SD) • Amsler-grid analysis • functional tests like multifocal Electroretinogram, mesoptometry, perimetry • ETDRS-Best corrected visual acuity • visual function questionnaire NEI-VFQ-25 | — |
Countries
Germany
Contacts
Public ContactJan Tode
Medizinische Hochschule Hannover
Outcome results
None listed