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

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

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.

Study Overview

• Status: Completed
• Conditions: Age Related Macular Degeneration

• Study Type: Observational
• Enrollment (Actual): 250

Contacts and Locations

Study Locations

• France
  • Creteil
    • Créteil, Creteil, France, 94000
      • Marciano Joelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Description of the patient's feelings	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.	up to 1 month after diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
score of general satisfaction	the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)	up to 1 month after diagnosis
score on a comprehension quiz on AMD		up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations		up to 1 month after diagnosis
Score on a composite score evaluating the clarity of medical explanations		between 6 months and 1 year of follow-up
score of satisfaction of announcement conditions		up to 1 month after diagnosis
score of satisfaction of announcement conditions		between 6 months and 1 year of follow-up
score of satisfactions regarding the clarity of the disease course and treatment explanations		between 6 months and 1 year of follow-up
Score on the anxiety PHQ9 questionnaire		between 6 months and 1 year of follow-up
Score on the anxiety GAD7 questionnaire		between 6 months and 1 year of follow-up

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2017
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): October 19, 2018

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (Estimate): January 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: diagnosis annoucement; patient's feelings
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: PANDA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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