Status:
COMPLETED
Evaluate the Quality of Life of Patients With AMD
Lead Sponsor:
Centre Hospitalier Universitaire Dijon
Conditions:
Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Brief Summary
Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems tha...
Eligibility Criteria
Inclusion
- \- For the 2 populations studied
- Persons who have given consent to take part
- Persons aged 50 years or older
- Willing and able to attend all of the scheduled visits and evaluations
- Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
- Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
- Diagnosed for less than 3 years
- MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m
- For patients with secondary atrophic AMD
- • Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.
Exclusion
- General criteria
- Persons without national health insurance cover
- Physical or mental disability ruling out participation
- Inability to sign the written consent form, adults under guardianship
- Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
- Adults under guardianship
- General medical history
- • Uncontrolled AHT
- Ophthalmological history
- Severe non-proliferative or proliferative diabetic retinopathy
- Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
- Corneal disease that could impair vision
- Monogenic macular dystrophy or toxic maculopathy
- History of uveitis
- Amblyopia of the eye concerned
- Intraocular surgery in the 3 months preceding inclusion
- History of cornea transplantation in the studied eye
- Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck
- Ophthalmological examination
- Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
- Active infection in either eye
- Central anterior serous or active retinopathy in either eye
- Choroid neo-vascularisation
- Active serous retinal detachment
- Refractive error less than -15D or more than +10D
Key Trial Info
Start Date :
August 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 3 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03242083
Start Date
August 8 2017
End Date
December 3 2019
Last Update
January 23 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU Dijon Bourgogne
Dijon, France, 21079