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

January 22, 2020 updated by: Centre Hospitalier Universitaire Dijon

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CHU Dijon Bourgogne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Change compared with baseline score at month 6, month 12 and month 18
Change compared with baseline score at month 6, month 12 and month 18

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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