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Completed

NCT Number: NCT03035461

Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration

Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina's thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".

Vascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.

After diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.

The aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Marciano Joelle

Créteil, Creteil, 94000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patient up to 55 years old
  • wet AMD
  • diagnostic questionnaire group: patient being announced with AMD for less than 1 month
  • disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months

Exclusion criteria

  • dry AMD
  • patient under 55 years old
  • patient who doesn't speak French
  • patient carrying an ophtalmologic genetic disorder

Treatment and study plan

Primary outcomes

  1. Description of the patient's feelings

    Time frame: up to 1 month after diagnosis

    A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.

Secondary outcomes

  1. score of general satisfaction

    Time frame: up to 1 month after diagnosis

    the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)

  2. score on a comprehension quiz on AMD

    Time frame: up to 1 month after diagnosis

  3. Score on a composite score evaluating the clarity of medical explanations

    Time frame: up to 1 month after diagnosis

  4. Score on a composite score evaluating the clarity of medical explanations

    Time frame: between 6 months and 1 year of follow-up

  5. score of satisfaction of announcement conditions

    Time frame: up to 1 month after diagnosis

  6. score of satisfaction of announcement conditions

    Time frame: between 6 months and 1 year of follow-up

  7. score of satisfactions regarding the clarity of the disease course and treatment explanations

    Time frame: between 6 months and 1 year of follow-up

  8. Score on the anxiety PHQ9 questionnaire

    Time frame: between 6 months and 1 year of follow-up

  9. Score on the anxiety GAD7 questionnaire

    Time frame: between 6 months and 1 year of follow-up

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal Creteil

Other

Registry information

Official study title

Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA

Acronym: PANDA

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 30, 2017
Registry last updated
Aug 4, 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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