Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated...
Age-related Macular DegenerationPolypoidal Choroidal VasculopathyThis study compared the effect of ranibizumab administered as monotherapy versus ranibizumab administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of this study provided long-term safety and efficacy data used to generate further guidance on the management of patients with PCV.
HELP Therapy for Dry AMD
Non-exudative (Dry) Age-related Macular Degeneration (AMD)This is an open-label, single center clinical investigation to evaluate the efficacy and safety of Heparin-induced Extracorporeal Lipoprotein Precipitation (H.E.L.P.) Therapy as a treatment for non-exudative (dry) Age-related Macular Degeneration (AMD). A total of 14 clinic visits are scheduled, one baseline visit, 8 visits for H.E.L.P. therapy treatments (to be performed over a period of 12 weeks for each patient) and 5 follow-up visits to be performed one week following the 4th H.E.L.P. therapy session and 12 weeks, 24 weeks, 36 weeks and 52 weeks after the final H.E.L.P. therapy session.
TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection...
Neovascular Age Related Macular Degeneration (AMD)Open Angle GlaucomaThis is a prospective, open label study assessing the 24-hour IOP patterns using TF in patients undergoing anti-VEGF injection for the treatment of neovascular AMD (age related macular degeneration). The study will be proposed to patients with AMD and patients with AMD and concomitant open angle glaucoma (OAG). The study will be conducted in two stages. In both stages, patients will remain ambulatory and will be encouraged to follow a schedule as close to their usual lifestyle as possible, with the exception of particular activities such as caffeine intake, playing wind instruments, yoga and strenuous exercise. A patient diary will be distributed for the capture of patient activities during the TF pattern recording. Upon completion of each session, the CLS (contact lens sensor) will be removed and a final ophthalmic examination will be conducted. In the first stage of the study, 20 patients with neovascular AMD with an IOP in the normal range and no concomitant glaucoma will be recruited. After having signed and dated the patient informed consent form, patients will undergo an initial ophthalmic examination. One eye will be selected for the study. If both eyes are eligible, the study eye will be selected in random manner. All 20 AMD patients will receive two 24-hour recording sessions (S) with the TF CLS, at monthly interval. In the first session (S1) anti-VEGF injection will be carried out according to the study center standard protocol. For the second 24-hour TF recording session (S2), patients will be randomly distributed into three groups. Group A, consisting of 5 patients, will receive anti-VEGF injection with a different anti-VEGF substance as compared to S1. Group B, also consisting of 5 patients, will receive anti-VEGF without sclerotomy occlusion after injection as compared to S1. Finally, group C, including 10 patients, will receive anti-VEGF in a different dose (injection volume) as compared to S1. The randomization ratio between groups A, B and C is 1:1:2. The overall study duration for an eligible patient in the first stage of this study is limited to 5 weeks. If in the first stage of this study an injection protocol is identified that provokes significantly lesser elevation on the TF pattern, the alternative injection protocol will be evaluated against the current standard protocol. For the second stage, 30 patients of whom 15 with neovascular AMD and 15 with neovascular AMD and concomitant OAG will be recruited. After giving informed consent and confirmation of eligibility, all patients will receive two 24-hour TF CLS recording sessions (S3 and S4) at monthly interval, during which anti-VEGF injection according to the standard and alternative protocol will be carried out in random sequence. The overall study duration for a patient in the second stage of the study is limited to 5 weeks. The study has been planned to recruit 20 eligible patients in the first stage within 12 weeks from the date of initiation. The second stage will recruit 30 patients within 16 weeks. Hence the overall study duration from the first patient accrued into the study until last patient out equates to about 33 weeks. Allowing for a database lock within 4 weeks of study completion, a preliminary statistical report on the primary efficacy endpoint is foreseen within 2 weeks thereafter.
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections...
Neovascular Age-related Macular DegenerationThe purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Study of Human Central Nervous System Stem Cells (HuCNS-SC) in Age-Related Macular Degeneration...
Age Related Macular DegenerationMacular Degeneration1 moreThe purpose of this Phase I/II study is to investigate the safety and preliminary efficacy of unilateral subretinal transplantation of HuCNS-SC cells in subjects with geographic atrophy secondary to age-related macular degeneration.
Efficacy and Safety of Squalamine Lactate Eye Drops in Subjects With Neovascular (Wet) Age-related...
Neovascular Age Related Macular DegenerationThe purpose of this study is to evaluate the safety and efficacy of topical ophthalmic squalamine lactate eye drops in treating patients with neovascular age-related macular degeneration (wet AMD), a degenerative retinal eye disease that causes a progressive, irreversible, severe loss of central vision.
Treat & Extend Treatment With 0.5mg Ranibizumab vs Monthly Treatment With 0.5mg Ranibizumab
Macular DegenerationTREX is a phase IIIb, multicenter, randomized, controlled clinical study. Subjects will be randomized 1:2 to "monthly" (control arm) or "treat and extend" protocol (comparator arm) respectively. TREX assess the safety, tolerability and efficacy of intravitreal injections (IVT) of 0.5mg ranibizumab given monthly for up to 100 weeks followed by pro re nata (PRN) treatment for 56 weeks compared to a Treat and Extend protocol for 156 weeks in patients with wet age-related macular degeneration (AMD). Subjects treated in a treat and extend protocol receive 3 consecutive IVT 0.5 mg ranibizumab (visits 2, 4 and 5). Starting at week 8, if a subject has achieved a "dry" macula; signs of active exudation have resolved will begin a Treat and Extend protocol (visits lengthened by 2 week intervals every visit a dry macular is maintained). At the beginning of the 104-week endpoint subjects initially randomized to the TREX cohort will transition to PRN re-treatment when there is no exudative disease activity at the 12-week interval.
A Safety And Efficacy Study Of ALG-1001 In Human Subjects With Wet Age-Related Macular Degeneration...
Macular DegenerationThe general objective of this study is to evaluate the safety and efficacy of ophthalmic intravitreal injections of ALG-1001 in human subjects with wet age-related macular degeneration (Wet AMD). This study builds upon the safety and efficacy results of numerous animal studies and an earlier Phase I Human Study in end-stage diabetic macular edema patients.
Intravitreal Bone Marrow-Derived Stem Cells in Patients With Macular Degeneration
Age Related Macular Degeneration and StargartdThe purpose of this study is to evaluate the behavior of intravitreal injection of of autologous bone marrow stem cells in patients with age related macular degeneration.
Safety and Efficacy of Intravitreal LFG316 in Wet Age Related Macular Degeneration (AMD)
Neovascular Age-elated Macular Degeneration (Wet AMD)Exudative Macular DegenerationThis study will assess the safety and efficacy of LFG316 in patients with age related macular degeneration.