Study to Evaluate an 8 mg Aflibercept (EYLEA®) Prefilled Syringe (PFS)
Diabetic Macular Edema (DME)Neovascular Age-Related Macular Degeneration (nAMD)Regeneron Pharmaceuticals developed a single-dose glass pre-filled syringe (PFS) to deliver 8 mg aflibercept. The PFS is a convenient device that contains the study medication that will be injected in your study eye. A PFS offers a sterile, single dose of study drug within the syringe; this eliminates the need for the retina specialist to prepare the injection syringe from a separate vial. This Phase IIIb study is focused on patients with diabetic macular edema (DME) and neovascular (wet) age-related macular degeneration (nAMD). The main aim of the study is to evaluate if the 8 mg aflibercept PFS allows for successful preparation and administration of 8 mg aflibercept by retina specialists. The study will also assess the safety of 8 mg aflibercept PFS use. Regeneron will use the information from the study to better understand if the PFS can be used safely and effectively by retina specialists to administer 8 mg aflibercept.
Photobiomodulation for Dry Age Related Macula Degeneration
PhotobiomodulationAge-Related Macular DegenerationThe study will investigate the effect of photobiomodulation treatment on the risk of developing late age related macula degeneration (AMD) in the study eye in patients with wet AMD in the fellow eye.
Prospective triAl of Modified Treat-and-extend Regimens With BroLucizumab in pachychOroid Neovasculopathy...
Age-Related Macular DegenerationPachychoroid NeovasculopathyPNV is a recently described clinical entity; therefore, studies about treatment efficacy and safety are few, with limited follow-up and a small number of participants. Treatment is based on intravitreal anti-VEGF injections, similar to neovascular AMD. According to reported results however, efficacy seems different in fluid reabsorption among anti-VEGF agents. A newly developed anti-VEGF molecule for the treatment of neovascular AMD, brolucizumab, has been shown in clinical studies to have longer durability and improved visual outcomes using a q12-week regimen, thus having the potential to reduce treatment burden and serve as an important therapeutic tool in the management of neovascular AMD. Nevertheless, there have been no reports specifically focusing on the efficacy of brolucizumab in the treatment of PNV. The purpose of this study is to evaluate the efficacy and safety profile of the modified treat-and-extend regimen to 64 weeks by intravitreal brolucizumab injection in eyes with treatment-naive pachychoroid neovasculopathy (PNV) patients.
Maximum Treatment Interval With Aflibercept T&E
Neovascular Age-related Macular DegenerationTo evaluate the duration of effectiveness of anti-VEGF (Aflibercept) by analyzing the percentage of patients whose maximum treatment interval is extended to 16 weeks and beyond in 24 months and their long-term remission.
Retinal Oxygenation Estimation Trial With Mantis Photonics Hyperspectral Camera
Glaucoma EyeMacular Degeneration2 moreAn explorative study of the Mantis Photonics hyperspectral camera for retinal imaging and estimation of retinal oxygenation. Primary objective: To evaluate the performance of the hyperspectral camera for non-invasive retinal examination in order to improve the diagnosis of diseases affecting the retina or central nervous system. Secondary objective: To investigate the possibilities of the use of a hyperspectral camera for non-invasive retinal examination.
Evaluation of Visual and Task Performance
GlaucomaMacular Degeneration4 moreBetter understand the impact of visual impairment on daily task performance in patients with eye diseases of the visual pathways, such as glaucoma and age-related macular degeneration (AMD). Longitudinal study, with biannual visits, including patients with: glaucoma, suspected of having glaucoma, non-glaucomatous optic neuropathies, AMD, retinal degenerations, other diseases involving the visual pathways, besides healthy controls. Subjects will perform standard ophthalmological exams, and the following research tests: psychophysical, eye tracking, electroencephalogram, driving simulator, virtual reality, balance assessment, and questionnaires. This proposal also includes an investigation of the ability of longitudinal brain-computer interface (BCI) multifocal steady-state visual-evoked potentials (mfSSVEP) parameters in detecting glaucoma progression. We hypothesize that BCI mfSSVEP data will be able to successfully detect progression and measure rates of change, as compared to functional assessment by standard automated perimetry (SAP) and structural assessment by optical coherence tomography.
Adjunct Episcleral Brachytherapy for PCV
Age-Related Macular DegenerationPolypoid Choroidal VasculopathyThis study is investigating the use of episcleral brachytherapy (ESB) adjunct to aflibercept compared to aflibercept monotherapy for the treatment of polyploid choroidal vasculopathy (PCV) in patients experiencing an inadequate response to anti-VEGF monotherapy.
Phase I/II Follow-up Study of SAR422459 in Patients With Stargardt's Macular Degeneration
Stargardt's DiseasePrimary Objective: To evaluate the long-term safety and tolerability of SAR422459 in patients with Stargardt's Macular Degeneration. Secondary Objective: To assess: Safety Biological activity
Advancing Understanding of Transportation Options
Diabetic RetinopathyMacular Degeneration30 moreThis Stage II randomized, controlled, longitudinal trial seeks to assess the acceptability, feasibility, and effects of a driving decision aid use among geriatric patients and providers. This multi-site trial will (1) test the driving decision aid (DDA) in improving decision making and quality (knowledge, decision conflict, values concordance and behavior intent); and (2) determine its effects on specific subpopulations of older drivers (stratified for cognitive function, decisional capacity, and attitudinally readiness for a mobility transition). The overarching hypotheses are that the DDA will help older adults make high-quality decisions, which will mitigate the negative psychosocial impacts of driving reduction, and that optimal DDA use will target certain populations and settings.
Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)
Age-related Macular DegenerationA device has been developed that has eye trackers integrated within the Head Mounted Display (HMD) and can remap text and images around the scotoma in real time to prevent information loss from a central scotoma. It can also carry out other types of image processing such as contrast enhancement and image magnification. The aim of this study is to assess the efficacy of this device on the visual performance of participants suffering from central vision loss, with and without remapping