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OpenTrials
Completed

NCT Number: NCT03242083

Evaluate the Quality of Life of Patients With AMD

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.

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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quality of Life Questionnaire

Other

quality of life questionnaire

Primary outcomes

  1. responses to a quality of life questionnaire

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

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

Acronym: QUASAR

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 8, 2017
Registry last updated
Jan 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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