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Clinical Trials/NCT03242083
NCT03242083
Completed
Not Applicable

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

Centre Hospitalier Universitaire Dijon1 site in 1 country28 target enrollmentAugust 8, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-related Macular Degeneration
Sponsor
Centre Hospitalier Universitaire Dijon
Enrollment
28
Locations
1
Primary Endpoint
responses to a quality of life questionnaire
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 8, 2017
End Date
December 3, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

responses to a quality of life questionnaire

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

Study Sites (1)

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