Intermediate AMD
Conditions
Keywords
MacuTherm Trial, iAMD
Brief summary
The goal of this study is to demonstrate that photothermal therapy with the individually dosed treatment plan proposed by Macula Explorer delivered safely by Navilas® Laser System effectively improves the life of photoreceptors and reduces the progression of intermediate Age-related Macular Degeneration (iAMD) and preserves photoreceptors shown by Ellipsoid Zone Integrity (EZI). Participants will be randomized to either Treatment or Control Group. There will be 12 visits, monthly for the first 3 months, then quarterly until the end of the study after 2 years.
Interventions
DEVICEphotothermal therapy
Patients receive individualized photothermal therapy in the study eye
DEVICESham treatment
Patients receive sham treatment in the study eye
Sponsors
OD-OS MacuTherm GmbH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male, female, or diverse * Age of 60 to 90 years old * Clinically confirmed intermediate AMD (iAMD, AREDS category 3) with the presence of: * At least 3 large drusen (diameter \> 125 μm) within the inner ring of 3mm diameter of the ETDRS Grid centered on the fovea (with or without reticular pseudodrusen (RPE)) * combined with at least 1 of the following other signs: * Incomplete RPE and outer retinal atrophy (i-RORA) outside central 1mm ring and/or * Hyperreflective foci (HRF) adjacent to drusen (within 3 mm) * Best corrected visual acuity between 65 and 87 letters * Clear optic 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 * Willing to participate
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) * All the non-AMD eye diseases mentioned for the study eye as
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary endpoint is defined by preservation of Ellipsoid Zone Integrity (EZI). | 12 months | It is reached if at 12 months the EZI change from baseline is significantly better in the Treatment Group than in the Control Group. |
Secondary
| Measure | Time frame |
|---|---|
| Change in eyes of Treatment Group compared to eyes in Control Group compared to baseline to determine progression of Drusen within ETDRS sector (<6mm) | 24 months |
| Rate of eyes converting to geographic atrophy | 24 months |
| Rate of eyes converting to active exudative nAMD | 24 months |
| Loss in BCVA of > 3 lines compared to baseline | 24 months |
Countries
Germany
Contacts
CONTACTJan Tode, Prof. Dr. med.
PRINCIPAL_INVESTIGATORJan Tode, Prof. Dr. med.
OD-OS MacuTherm GmbH
Outcome results
None listed