Evaluate the Quality of Life of Patients With AMD

Age-related Macular Degeneration Clinical Trial

— QUASAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03242083
• Other study ID #: KAUFFMANN PCA 2016
• Status: Completed
• Start date: August 8, 2017
• Est. completion date: December 3, 2019

Study information

• Verified date: January 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 3, 2019
• Est. primary completion date: December 3, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• quality of life questionnaire
quality of life questionnaire

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	responses to a quality of life questionnaire		Change compared with baseline score at month 6, month 12 and month 18