Clinical trial NCT03242083: Evaluate the Quality of Life of Patients With AMD
Official title: Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-related Macular Degeneration
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2017-08-08
Enrollment: 28
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: During an ophthalmology consultation, the clinician who has established the diagnosis of primary atrophic or secondarily atrophic AMD (defined in 1.1.2) proposes to the patient fulfilling the aforementioned eligibility criteria to participate in the study.

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 that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.


Eligibility criteria: Inclusion Criteria:

- 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 Criteria:

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

Primary outcomes:
measure: responses to a quality of life questionnaire
timeFrame: Change compared with baseline score at month 6, month 12 and month 18
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References: