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Evaluate the Quality of Life of Patients With AMD

Evaluation de la Quality of Life in Secondary Atrophic Age-related Macular Degeneration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03242083
Acronym
QUASAR
Enrollment
28
Registered
2017-08-08
Start date
2017-08-08
Completion date
2019-12-03
Last updated
2020-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Macular Degeneration

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.

Interventions

OTHERquality of life questionnaire

quality of life questionnaire

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
responses to a quality of life questionnaireChange compared with baseline score at month 6, month 12 and month 18

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026