A Study Assessing AR-13503 Implant in Subjects With nAMD or DME
Neovascular Age-related Macular DegenerationDiabetic Macular EdemaFirst-in-Human Study of the Safety of AR-13503 Sustained Release Intravitreal Implant in Subjects with Neovascular Age-Related Macular Degeneration (nAMD) and Subjects with Diabetic Macular Edema (DME)
A Depot Formulation of Sunitinib Malate (GB-102) in Subjects With Neovascular (Wet) Age-related...
Neovascular Age-Related Macular DegenerationThe purpose of this study is to evaluate the safety and efficacy of single and repeated intravitreal injections of GB-102 in subjects with neovascular (wet) age-related macular degeneration.
Effect of Intravitreally Administered AIV007 in Subjects With nAMD
Neovascular Age-related Macular DegenerationTo determine safety, pharmacokinetics, and duration of effect of intravitreally administered AIV007 gel suspension in subjects with neovascular age-related macular degeneration
Safety and Bioactivity of AXT107 in Subjects With Neovascular Age-Related Macular Degeneration
Neovascular Age-Related Macular Degeneration (nAMD)This is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with nAMD.
Phase III Study Assessing the Efficacy, Safety and Immunogenicity of SOK583A1 Versus Eylea® in Patients...
Neovascular Age-related Macular DegenerationPurpose and rationale: To demonstrate similar efficacy, safety and immunogenicity of SOK583A1 and Eylea EU as per Eylea approved treatment regimen in patients with nAMD. The primary clinical question of interest is: Does SOK583A1 have similar efficacy as Eylea EU in terms of mean change in BCVA score in participants with nAMD who are anti-VEGF naive, without important protocol deviations and adherent to the treatment and completed the treatment to Week 8?
The SPECTRUM Study: An Observational Study to Learn More About How Well Aflibercept 8 mg Works in...
Visual ImpairmentNeovascular Age-related Macular Degeneration (nAMD)1 moreThis is an observational study in which only data are collected from people who have already been prescribed aflibercept 8 mg by their own doctors. In this study, data from adults with visual impairment due to neovascular age-related macular degeneration (nAMD) or diabetic macula edema (DME) will be collected and studied. Visual impairment is any degree of vision loss that affects a person's ability to perform daily activities. nAMD is an eye disorder that causes vision loss due to the growth of abnormal blood vessels that leak blood or retinal fluid into the macula (the central part of the retina). nAMD is a leading cause of vision loss for people aged 50 and older. DME is a diabetes-related eye disorder. In DME, the macula swells up due to fluid leakage from damaged blood vessels, resulting in vision problems. Aflibercept 8 mg is a drug that is injected into the eye. It works by blocking a protein called vascular endothelial growth factor (VEGF) which causes abnormal growth and leakage of blood vessels at the back of the eye. Aflibercept 8 mg has been submitted for approval for the treatment of visual impairment due to nAMD and DME based on the results from 2 studies called PHOTON and PULSAR. This study will begin once approval is obtained. Currently, no real-world data are available for aflibercept 8 mg. The main purpose of this study is to collect more information about how well aflibercept 8 mg injection works in people with nAMD and DME. This study will include participants who have not received any prior treatment for nAMD or DME and participants who have. The main information that researchers will collect: the change in vision test scores called the best corrected visual acuity (BCVA) after 12 months of treatment. Data will be collected from November 2023 to August 2027 and will cover a period of up to 24 months per participant. The data will be collected using medical records and by interviewing the patients during regular visits that take place in routine practice. Researchers will observe participants from the first injection of aflibercept 8 mg until the end of the observation. In this study, only available data from regular visits will be collected. No visits or tests are required as part of this study.
Efficacy and Safety Study of ESBA1008 Versus EYLEA®
Exudative Age-Related Macular DegenerationThe purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.
Efficacy and Safety of Ranibizumab 0.5 mg Administered as Two Alternative Dosing Regimens in Chinese...
Neovascular Age-related Macular DegenerationThe study evaluated the efficacy and safety of two different dosing regimens of ranibizumab (either monthly injections or injections as-needed based on the stability of a patient's vision) in Chinese patients with wet age-related macular degeneration (AMD) . This study was to provide long-term safety data in the treatment of Chinese patients with wet AMD.
Aflibercept After Ranibizumab in Exudative Age-related Macular Degeneration
Macular DegenerationWet Macular Degeneration3 moreThe purpose of the current study is to evaluate the ability of Eylea to induce a regression of PED height on patients previously extensively treated by Lucentis. The regimen proposed for this study is the 3 monthly injection followed by a 6 weeks interval injection until week 26.
ESBA1008 Safety, Tolerability and Effects in Wet Age-Related Macular Degeneration (AMD) Patients...
Exudative Age-Related Macular DegenerationThe purpose of this study was to assess the safety, tolerability, and the effects of treatment on ocular outcomes following a single intravitreal administration of ESBA1008 compared with LUCENTIS® in patients with exudative age-related macular degeneration (AMD).