Clinical trial NCT04982484: Reading Speed Improvements in Wet-AMD Patients After Ranibizumab Treatment
Official title: Effects of Anti-VEGF Injections (Ranibizumab, Lucentis) on Visual Acuity, Reading Speed and Retinal Thickness in Wet-AMD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ophthalmopathy
Wet Macular Degeneration
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University of Pecs
First posted: 2021-07-29
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Macular oedema due to WET-AMD

Brief summary: AMD (age-related macular degeneration), is the leading cause of blindness in individuals over the age of 55. There is no cure for wet-AMD but anti-VEGF treatments significantly minimize the vision loss over time. To study the correlation between anti-VEGF injection bevacizumab (Lucentis), visual acuity, macular thickness and last but not least reading speed in wet-AMD patients.

The study was conducted on 50 eyes of 50 wet-AMD patients. Subjects were monthly treated with an intra-vitreal Lucentis injection for 3 months; further injections were given when a loss of 5 or more letters of visual acuity was observed and/or when the retinal thickness in the affected macular area increased by 100 µm. In addition to a full ophthalmological examination reading speed was investigated via the Radner reading chart before and 3 months after treatment. The collected data was analyzed using paired t-tests.

Detailed description: Age related macular degeneration also known as AMD is the most common cause of blindness in Europe, the USA and other industrialized countries. AMD appears in people above the age of 50. The origin despite intensive research and many clinical trials is not fully understood. However, it is assumed that AMD is multifactorial. It has metabolic, genetic and environmental components that play crucial roles in the development of the disease. The interaction of different etiologic risk factors in chronic changes in the macular area (choroid, Bruch's membrane, and retinal pigment epithelium) is reflected in a slowly progressive loss of vision. AMD is classified into a dry and a wet form. The dry form represents 80% of all AMDs and it only leads to blindness in 10% of the cases. Dry AMD is characterized by drusen, pigmentary changes (hypo/hyper-pigmentation and-or atrophy of the photoreceptors with the RPE and the choriocapillaries as well). A successful therapy for this form is still unknown, but studies have shown that a change in lifestyle and dietary supplements (vitamins) can slow the progression of the disease. The wet form represents 20% of AMDs, but in 80-90% of the cases patients may experience rapid and serious vision loss. The vision loss is due to the formation of abnormal blood vessels, which are leaking in the choroid because they have no barrier and cause accumulation of blood and fluid in the intraretinal and/or subretinal space and ultimately leading to an irreversible scarring stage (Kuhnt-Junius scar). Against wet-AMD, there are numerous treatment possibilities, and they are very efficient. The treatment is mainly on the basis of anti-angiogenesis, the anti-vascular endothelial growth factor drug (Anti-VEGF) comes as an intravitreal injection ranibizumab (Lucentis). With only a few articles focusing on the reading speeds as a criteria in patients with macular disorders, analyses of the evolution of the reading speed of Wet-AMD patients are needed before and after Lucentis injections with the use Radner's reading chart : The Radner reading chart is a highly standardized multilingual reading test system that was developed in 1998 for clinical practice.

Eligibility criteria: Inclusion Criteria:

* AMD, Age related macular degeneration (Wet-form)

Exclusion Criteria:

* Age related macular degeneration (Dry-form)
* Diabetic macular oedema
* Other related macular oedemas

Primary outcomes:
measure: Reading speed day 0
timeFrame: day 0
measure: Reading speed M3
timeFrame: month 3
Secondary outcomes:
measure: Visual acuity using the ETDRS chart day 0
timeFrame: day 0
measure: Visual acuity using the ETDRS chartM3
timeFrame: month 3
measure: Maculare thickness Day0
timeFrame: day 0
measure: Maculare thickness M3
timeFrame: Month 3
Other outcomes:
Locations:
Study officials:
affiliation: CHR Metz Thionville Hopital de Mercy
name: Georges Jr Hayek, MD
role: PRINCIPAL_INVESTIGATOR
References: