dry age-related macular degeneration
Conditions
Interventions
Group 1: Study Eye: Photobiomodulation treatment
Patients with dry AMD in both eyes use the MACULIGHT device at home on their closed eyelids on 3 days per week for 12 months.
Group 2: Fellow Eye: Con
Sponsors
Ciromed GmbH
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age = 50 years; independent of gender 2. Subjects capable of home therapy 3. Agree to participate in the study by signing the consent document providing information about the study and take part in all examinations and assessments as required. Study Eye and Control Eye: 4. Dry AMD (AREDS classification early to late stage) 5. multiple small drusen or a few intermediate – sized (63-124 µm in diameter) drusen, or macular pigmentary changes 6. Visual acuity 0.4 to 1.0 (Snellen decimal) 7. Difference between study and control eye = 3 visual acuity levels
Exclusion criteria
Exclusion criteria: 1. Visually significant disease in any ocular structure apart from dry AMD (i.e., macular hole, Irvine-Gass Syndrome) 2. cRORA region(s) within the central area of 500 µm radius from central fovea 3. cRORA with the area size (of each) of 1.9 mm² (0.75 Disk Area) or more 4. multiple cRORA with the total area size of 3.8 mm² (1.5 Disk Area) or more 5. Wet AMD (present as well as past) 6. IVOM Therapy (present as well as past) 7. Amblyopia 8. Media opacity which impairs visual acuity 9. Advanced Glaucoma 10. Advanced Cataract 11. Severe Dry Eye 12. Advanced corneal endothelial dystrophy 13. Photosensitivity to red light 14. Long-term (>12 weeks) use of photosensitizing agents 15. At Baseline planned ocular surgery within study duration 16. Pregnancy 17. A history of photobiomodulation treatment 18. A history of open intraocular eye surgery in either eye within the past 3 weeks of baseline. 19. Subjects who cannot learn, due to physical or cognitive impairment, how to use the device or who have no one to assist them at home.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - ? NL-BCVA (Normal Luminance - Best Corrected Visual Acuity) at 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| - ? in NL/LL - visual acuity (Normal & Low Luminance) at 1, 3, 6, 9 and 12 months - ? in NL/LL - contrast sensitivity (Normal & Low Luminance) at 1, 3, 6, 9 and 12 months - rate of conversion to neovascular or atrophic AMD during 12 months - growth of atrophic region at 6 and 12 months - Retina Layers Thickness (RLT) at 6 and 12 months - Change of iRORA/cRORA during 12 months - ? mean Fluorescence Lifetime (tm) in ETDRS grid at 3 and 9 months - patient's subjective assessment Questionnaire at 3, 6 and 12 months - Adherence to treatment schedule during 12 months - ? TBUT at 1, 3, 6, 9 and 12 months - Safety outcomes at 12 months | — |
Countries
Germany
Outcome results
None listed