Study of Nutritional Supplementation in Patients With Unilateral Wet AMD
Wet Macular DegenerationRetinal diseases are currently the leading cause of legal blindness in the developed world. Among these disorders, age-related macular degeneration (AMD) is one of the most prevalent conditions in individuals over 55 years of age. Late AMD, the most severe presentation of the disease, clinically manifests as either geographic atrophy (dry form) or choroidal neovascularization (CNV) (wet form). Although patients with wet AMD only represent 10% of the total cases, CNV is the main and most serious cause of central vision loss. At present, the treatment of wet AMD comprises intraocular injections of certain antiangiogenic agents which act by blocking VEGF (vascular endothelial growth factor). No effective treatment is yet available for dry AMD, though the AREDS (Age-Related Eye Disease Study) has shown that the administration of antioxidant supplements is able to slow progression of the disease. Such vitamin supplements are also indicated in patients who already have severe AMD (both exudative and atrophic) in one eye, since the risk of progression in these cases is high. Recent studies involving new antioxidant and antiangiogenic molecules such as resveratrol, present in grapes and wine, have also revealed great efficacy in slowing the progression of advanced AMD. Hydroxytyrosol is another polyphenol with important antioxidant and antiinflammatory effects in the RPE. Considering the above, the present randomized, multicenter interventional study involving Spanish and Portuguese patients with unilateral wet AMD was designed to compare the effects of two different nutritional supplements: one containing the antioxidants and minerals recommended by the AREDS at doses that can be used in the European Union (Theavit), and the other comprising these same substances plus omega-3 fatty acids (lipidic antioxidant), lutein (pigment protecting against light-induced damage) and resveratrol (antioxidant and antiangiogenic agent) (Retilut).
Clinical Study on the Efficacy and Safety of BAT5906 Injection
Wet Age-related Macular DegenerationThis study is a multi-center, open, and phase II clinical study to evaluate the efficacy and safety of BAT5906 injection in patients with wet age-related macular degeneration. The results of the BAT5906 Phase I study show that it is safe from 0.3-4.0 mg, and that higher doses (2.5 mg and 4 mg) may be substituted for the duration of maintenance efficacy; drugs with the same target (such as brolucizumab and Abecip) have also been found in clinical studies High doses can extend the interval and reduce the frequency of administration. Therefore, in this study, two doses with better safety and efficacy were selected, once every 4 weeks, followed by 3 consecutive injections for treatment as needed, and preliminary exploration of the best clinical effective dose and replacement frequency
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 Compared With Intravitreal Aflibercept...
Wet Age-related Macular DegenerationThis Phase 3 study will evaluate the efficacy and safety of KSI-301 compared to aflibercept, in participants with neovascular (wet) age-related macular degeneration (wAMD)
CB-PRP in Retinitis Pigmentosa and Dry Age-related Macular Degeneration
Retinitis PigmentosaDry Age-related Macular DegenerationThe study will provides the enrollment of patients with genetic retinal dystrophies with primary rod impairment and dry age-related macular degeneration (Geographic type) A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group. A complete morpho-functional ophthalmological evaluation will be performed in all patients at each control.
RBM-007 in Treatment naïve Exudative Age-related Macular Degeneration
Age Related Macular DegenerationThis study is a single-center, open label, 4-month study, designed to evaluate the safety and treatment efficacy of RBM-007 in patients with intraretinal or subretinal edema due to previously untreated neovascular AMD. Up to 5 subjects will be randomized to receive study medication. Study treatment will be administered by intravitreal injections.
Efficacy and Safety of the Aflibercept FYB203 Biosimilar in Comparison to Eylea® in Patients With...
Neovascular Age-related Macular DegenerationThis is a randomized, double-masked, multicenter study to evaluate the efficacy and safety of FYB203 compared to Eylea® in patients with neovascular age related macular degeneration.
An Extension Study Assessing the Efficacy and Safety of Brolucizumab in a Treat-to-Control Regimen...
Neovascular Age-related Macular DegenerationThe purpose of this extension study is to evaluate the efficacy and safety of brolucizumab used in a Treat-to-Control-regimen for treatment of patients with neovascular age-related macular degeneration who have completed the CRTH258A2303 (TALON) study. The main objective is to assess brolucizumab's potential for long durability up to 20 weeks. All eligible participants will be treated with brolucizumab regardless of their treatment in the TALON study. The study period is 56 weeks including post-treatment follow-up.
A 4 Week Study With BI 144807 in Patients >= 50 Years With Wet Age Related Macular Degeneration...
Wet Macular DegenerationThe present trial will use an open label design to investigate the effect of BI 144807 on central 1-mm retinal thickness and presence of neovascular leakage in newly diagnosed wAMD patients. A further objective is to collect data on adverse events, vital signs, ECG and clinical laboratory parameters of BI 144807 in the same patient group.
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With...
Neovascular Wet Age-related Macular Degeneration (AMD)The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related...
Macular DegenerationThis multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.