Clinical Trials Logo

Clinical Trial Summary

Age-related macular degeneration (AMD) is a leading cause of blindness in people over 50. Neovascular AMD, the most serious and severe form, is characterized by the appearance, spread and growth of subretinal new vessels. One of the major molecular mediators is vascular endothelial growth factor (VEGF). Intra-vitreous (IVI) injection of an anti-VEGF can slow the progression of neovascular AMD and stabilize vision in the majority of cases. Aflibercept (Eylea®) is one of the anti-VEGF molecules approved in Belgium to treat neovascular AMD. At the start of its use, aflibercept was first injected monthly and then according to the PRN "reactive" protocol (Pro Renata). Over time, a new treatment strategy has emerged: the "treat-and-extend" (T&E). This is individualized patient care, the objective of which is to reduce the frequency of injections while ensuring inactivity of the disease. This begins with the loading dose, i.e. 3 injections given 4 weeks apart. Thereafter, the interval is lengthened in increments of 1 or 2 weeks provided that the visual and anatomical results remain stable. In the event of deterioration, the interval is shortened while keeping a minimum of 4 weeks between each IVI. The efficacy and safety of aflibercept, when used in a proactive T&E regimen, was demonstrated in the randomized controlled trial, ALTAIR. However, data on T&E used in practice is still lacking. routine, and particularly the number of injections and treatment intervals over a minimum 24 month treatment period. The aim of this retrospective study carried out at the CHU Brugmann is to determine the number of injections and the intervals necessary to have encouraging results in terms of visual acuity, over a treatment period of at least one year.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT04891835
Study type Observational
Source Brugmann University Hospital
Contact
Status Completed
Phase
Start date April 13, 2021
Completion date September 22, 2021

See also
  Status Clinical Trial Phase
Recruiting NCT05984927 - NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT05536297 - Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy Phase 3
Recruiting NCT04101604 - Biomarkers of Common Eye Diseases
Completed NCT04005352 - Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON) Phase 3
Withdrawn NCT02873351 - A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration Phase 2
Active, not recruiting NCT02802657 - Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration Phase 4
Not yet recruiting NCT02864472 - Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose Phase 4
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
Completed NCT01445548 - Sirolimus for Advanced Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT02035722 - Intravitreal Injections-related Anxiety Phase 2/Phase 3
Completed NCT01175395 - 20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD) Phase 1/Phase 2
Recruiting NCT01048476 - Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration Phase 1/Phase 2
Active, not recruiting NCT01174407 - Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration N/A
Terminated NCT00712491 - Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration Phase 1/Phase 2
Completed NCT00345176 - Age-Related Eye Disease Study 2 (AREDS2) Phase 3
Completed NCT02140151 - Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration Phase 1/Phase 2
Completed NCT02555306 - A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration Phase 1/Phase 2
Recruiting NCT04796545 - Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration N/A
Completed NCT03166202 - Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
Completed NCT01397409 - Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD) Phase 2