Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04982484
Study type Observational
Source Centre Hospitalier Régional Metz-Thionville
Contact
Status Completed
Phase
Start date September 1, 2010
Completion date August 1, 2013

See also
  Status Clinical Trial Phase
Terminated NCT04049266 - A Study to Evaluate the Efficacy and Safety of KSI-301, an Anti-VEGF Antibody Biopolymer Conjugate, Versus Aflibercept in Patients With Neovascular (Wet) Age-Related Macular Degeneration. Phase 2/Phase 3
Recruiting NCT01521065 - An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration Phase 2
Terminated NCT05038371 - Connective Tissue Growth Factor in Patients With Neovascular Age Related Macular Degeneration
Completed NCT03278262 - The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting
Completed NCT00590694 - Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments Phase 2/Phase 3
Completed NCT04516278 - A 3-month Study to Assess the Safety of ONS-5010 in Subjects With Visual Impairment Due to Retinal Disorders Phase 3
Completed NCT03844074 - A Clinical Effectiveness Study Examining the Efficacy and Safety of ONS-5010 in Subjects With Neovascular Age-related Macular Degeneration (AMD) Phase 3
Recruiting NCT05637255 - A Randomized, Double Masked, Parallel Group, Dose-finding Study to Evaluate SYL1801 in Patients With Neovascular Age-related Macular Degeneration (AMD) Phase 2
Completed NCT04756310 - Study of Nutritional Supplementation in Patients With Unilateral Wet AMD N/A
Active, not recruiting NCT05112861 - A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders Phase 3
Enrolling by invitation NCT03999801 - Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy Phase 2
Terminated NCT03699618 - Anti-VEGF Therapy for Subfoveal Hemorrhage in Patients With Neovascular Age-Related Macular Degeneration
Completed NCT01666821 - A Population-based Study of Macular Choroidal Neovascularization in a Chinese Population N/A
Completed NCT03022292 - The IAI-OCTA Study; a Study of OCT-Angiography Analysis Efficacy Phase 4
Completed NCT02944227 - Efficacy of Fixed Monthly Dosing of Ranibizumab in Neovascular Age-related Macular Degeneration Phase 4
Terminated NCT03452527 - Open-Label Study of Intravitreal ICON-1 in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration (AMD) Phase 2
Completed NCT01243086 - OZURDEX in Age Related Macular Degeneration as Adjunct to Ranibizumab Phase 2
Completed NCT03823300 - A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE) Phase 3
Recruiting NCT04420923 - Optimizing the Treatment Strategy for Age-related Macular Degeneration N/A
Completed NCT03954626 - Study to Collect Safety and ECG Data on Brolucizumab 6 mg Intravitreal Treatment in Patients With Wet AMD Phase 3