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NCT ID: NCT06271330 Not yet recruiting - AMD Clinical Trials

Multicenter Real-life Observational Study Switched Aflibercept or Ranibizumab to Faricimab in Patients With AMD.

FAR-WEST
Start date: April 2024
Phase:
Study type: Observational

Age-related macular degeneration (AMD) is a degenerative retinal disease. The prognosis of the exudative form was transformed by the introduction of the anti-VEGF monoclonal antibody treatments ranibizumab [1] and aflibercept [2] in the 2010s. In 2022, a new molecule, Faricimab, proved its efficacy in exudative AMD. It is a bi-specific monoclonal antibody against VEGF-A and ANG2. The drug has been granted marketing authorization in France, with reimbursement due to begin in October 2023 for naïve patients as well as for those already treated with ranibizumab or aflibercept. The main advantage of this compound [3] is that it extends the injection interval in the Treat and Extend (T&E) protocol, which is more extensive than with previous anti-VEGF agents. The patients included in the faricimab Phase III study were all naïve to any anti-VEGF treatment. In practice, faricimab is likely to offer hope to patients already treated with anti-VEGF with a short injection interval to lengthen the number of weeks between injections. As the treatment will be on sale in pharmacies from October 2023, a switch study from previous anti-VEGF drugs to faricimab would contribute to an initial real-life evaluation of the drug in this indication.

NCT ID: NCT05547633 Recruiting - AMD Clinical Trials

Detection and Management of Sinusitis in a Single-center Prospective Cohort of Patients With Exudative AMD (SINE)

SINE
Start date: January 20, 2023
Phase:
Study type: Observational

An inflammatory component associated with AMD has been highlighted by genetic associations of predisposition to AMD, as well as by the recently demonstrated link between AMD and periodontitis. Some patients followed at the Fondation Adolphe de Rothschild Hospital for wet AMD seemed to show an improvement of neovascular activity (less need for intravitreal injections of anti-VEGF) after treatment of their sinusitis. The investigators would therefore like to assess the link between AMD and sinusitis, an infection close to the site of AMD.

NCT ID: NCT05407636 Recruiting - Clinical trials for Wet Age-related Macular Degeneration

Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD

ASCENT
Start date: December 28, 2021
Phase: Phase 3
Study type: Interventional

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.

NCT ID: NCT05210803 Enrolling by invitation - AMD Clinical Trials

Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

Start date: December 20, 2021
Phase:
Study type: Observational

This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.

NCT ID: NCT05056025 Recruiting - AMD Clinical Trials

Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration.

REVERS
Start date: December 2, 2020
Phase: N/A
Study type: Interventional

A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.

NCT ID: NCT04796545 Recruiting - Clinical trials for Age-Related Macular Degeneration

Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration

Start date: September 13, 2022
Phase: N/A
Study type: Interventional

The objective of this study is to demonstrate the safety and effectiveness of the SING IMT (Smaller Incision New Generation Implantable Miniature Telescope) 3X implant in improving vision in patients with central vision impairment associated with end-stage Age-related Macular Degeneration (AMD). Eligible patients will be implanted with the SING IMT device and will be followed-up for a period of 12-months with post-operative ophthalmic exams and low-vision rehabilitation sessions.

NCT ID: NCT04739319 Recruiting - Clinical trials for Age-related Macular Degeneration

Project AMD: Comprehensive Characterisation of Age-Related Macular Degeneration and Its Progression

Project AMD
Start date: February 2, 2021
Phase:
Study type: Observational

Age-related macular degeneration (AMD) is the leading cause of irreversible vision loss worldwide, and nearly two million Australians have some signs of AMD. This proposed project is a prospective, observational study that seeks to to understand the underlying aetiology of AMD, factors associated with differences between age-related macular degeneration (AMD) phenotypes or severities, or between AMD and healthy individuals. It also seeks to understand the natural history of AMD progression and the factors associated with the rate of progression. In this project, the disease phenotype, genotype and severity and rate of progression will be determined based on non-invasive clinical imaging or functional assessment of the retina, from obtaining biological samples from the participants, or from patient-reported outcomes.

NCT ID: NCT04704921 Recruiting - Clinical trials for Wet Age-related Macular Degeneration

Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD

ATMOSPHERE
Start date: December 29, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

RGX-314 is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. RGX-314 is being developed as a potential one-time treatment for wet AMD.

NCT ID: NCT04537143 Withdrawn - AMD Clinical Trials

Image Biomarkers for Progression of AMD

IBPAMD
Start date: January 2021
Phase:
Study type: Observational

To study qualitatively and quantitatively the Imaging Biomarkers (IBs) on Multi-modal Imaging with Novel technologies (MINT), in order to understand their role in prediction of the Age-related Macular Degeneration (AMD) progression in eyes with and without treatment. The understanding of IBs will allow early detection of AMD, prediction of its evolution, and guidance for the best options for stratified/individualized treatment of AMD.

NCT ID: NCT04177069 Recruiting - AMD Clinical Trials

Evaluate the Improving Effects of Visucomplex Plus on Quality of Life in Patients With AMD

Start date: December 11, 2019
Phase:
Study type: Observational

This is an observational study in which patients affected by dry or wet AMD will be enrolled, after signing the Informed Consent, according to eligibility criteria. Patients, after signing the Informed Consent, will enter into a screening phase during which the concomitant medication, clinical history, physical examination (including smoking habits) will be checked and the inclusion/exclusion criteria will be assessed. Then, at the time of Baseline visit (V0) the eligible patients will be given Visucomplex Plus as monotherapy, 1 capsule daily after food, or for dry or wet AMD patients under treatment with a stable dose of an anti-VEGF drug, Visucomplex Plus, 1 capsule daily after food, upon physical decision. Screening phase and the baseline visit (V0) could coincide.