Evaluate the Quality of Life of Patients With AMD (QUASAR)

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

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.

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Other: quality of life questionnaire

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• France
  • Dijon, France, 21079
    • Chu Dijon Bourgogne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary atrophic AMD	Other: quality of life questionnaire; quality of life questionnaire
Secondary atrophic AMD	Other: quality of life questionnaire; quality of life questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
responses to a quality of life questionnaire	Change compared with baseline score at month 6, month 12 and month 18

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2017
• Primary Completion (Actual): December 3, 2019
• Study Completion (Actual): December 3, 2019

Study Registration Dates

• First Submitted: August 4, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 23, 2020
• Last Update Submitted That Met QC Criteria: January 22, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: KAUFFMANN PCA 2016

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No