VEGFA-targeting Gene Therapy to Treat Retinal and Choroidal Neovascularization Diseases
Neovascular Age-related Macular DegenerationDiabetic Macular Edema1 morePatients who respond to anti-VEGF therapy but with refractory retinal and choroidal neovascularization diseases including neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), and retinal vein occlusion-Macular edema (RVO-ME).
Compare the Efficacy and Safety of HLX04-O With Ranibizumab in Subjects With wAMD
Age Related Macular Degenerationthis study will compare the efficacy and safety of HLX04-O administered by IVT with ranibizumab in patients with active CNV secondary to AMD.
Subthreshold Laser Treatment in Intermediate Age-related Macular Degeneration With Nascent Geographic...
Age-Related Macular DegenerationThis study is a prospective, single centre, randomized, sham-controlled, double-masked, clinical trial which aims to investigate the effect of subthreshold nanosecond laser on disease progression in eyes with intermediate age-related macular degeneration (AMD) and nascent geographic atrophy by functional and anatomical outcomes. The study population will be individuals with high-risk intermediate age-related macular degeneration who meet all eligibility criteria. 60 subjects total (30 randomized to receive subthreshold nanosecond laser (SNL) treatment and 30 to receive sham treatment as per the 1:1 randomization). The study has a 12-month study period with four scheduled visits: screening, randomisation (first treatment), 6-month follow up visit (with second treatment where eligible), 12-month follow-up. The primary outcome is the proportion of laser-treated study eyes that develop late AMD compared to sham-treated study eyes over 12 months. The key secondary outcome is the change in retinal function of laser-treated study eyes compared to sham-treated study eyes over 12 months. Safety will be the proportion of laser-treated eyes that lose 10+ letters of vision (measured on a standard vision chart) compared to sham-treated eyes over 12 months.
Pivotal 1 Study of RGX-314 Gene Therapy in Participants With nAMD
AMDnAMD4 moreRGX-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.
Study of Zifibancimig in Participants With Neovascular Age-Related Macular Degeneration
Macular DegenerationThis is a first in-human study to investigate the safety, tolerability and efficacy of zifibancimig administered through intravitreal (IVT) injections and via the Port Delivery (PD) implant in participants with neovascular age-related macular degeneration (nAMD)
Study to Evaluate the Response to Supplementation With Postbiotics in Patients With Macular Degeneration....
AMDSoft Drusen4 moreA pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for...
Age-Related Macular DegenerationBackground: Age-related macular degeneration is a common eye disease in people over 50. The "dry" form of the disease can worsen into geographic atrophy, causing blind spots. Researchers want to learn if replacing older eye cells with younger ones can help treat this disease. Objective: To test the safety of putting cells inside the eye as a possible future treatment for dry age-related macular degeneration. Eligibility: People ages 55 and older who have geographic atrophy with loss of vision. People who have had "wet" macular degeneration in either eye are NOT eligible. Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Eye exam Eye photos Fluorescein angiography. An intravenous (IV) line is placed in an arm vein. A dye is injected. A camera takes pictures of the dye as it flows through the eyes' blood vessels. Electroretinography. An electrode is taped to participants' forehead. They sit in the dark. After 30 minutes, numbing eye drops and contact lenses are placed in their eyes. They watch flashing lights. Tuberculosis test Chest X-ray Electrocardiography. Sticky pads are placed on participants' chest to record the heart's electrical activity. Participants will have at least 14 study visits over 5 and a half years. They will repeat screening tests. Participants will have retinal pigment epithelium (RPE) transplantation surgery in one eye. For this, cells from participants' blood are turned into RPE cells. These cells are placed in their eye through a cut in their retina. They will get dilating eye drops, an IV line, and anesthesia that may make them sleep. A gas bubble will be put in their eye to help it heal. Participants will be contacted yearly for up to 15 years.
Learning Study: Improving Vision in Adults With Macular Degeneration
Macular DegenerationThe purpose of this study is to test whether a kind of brain stimulation called anodal transcranial direct current stimulation (a-tDCS) can be combined with perceptual learning to improve the ability of people with age-related macular degeneration (AMD) or juvenile macular degeneration (JMD) to read words presented to them on a computer screen better than if perceptual learning alone were used. In addition, secondary measures of visual acuity will also be examined to determine whether brain stimulation can allow patients to resolve finer details of an image. The proposed treatment is the application of a-tDCS onto the participant's head, with brain stimulation aimed at Primary Visual Cortex toward the occipital pole, while patients undergo six separate sessions of training. The investigators will test the ability of participants to read words before the start of the training sessions (pre test) and after the completion of all training sessions (post test). This is a between-subjects design, and half of the participants will receive true stimulation, and the other half will receive sham stimulation. The difference between the pre and post tests when receiving active stimulation will be compared to the difference when receiving sham stimulation, because the sham stimulation is not expected to influence reading beyond a placebo. The aim of the study is to examine the potential of concurrent brain stimulation and perceptual learning as an effective treatment for macular degeneration that may be used in conjunction with more traditional eye-based interventions. The investigators hypothesize that the brain stimulation will enable higher performance in the reading task after and secondary measures after perceptual training due to an increase in the cortical excitability of the stimulated brain cells.
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
Age-related Macular Degeneration (AMD)The primary objectives of the study are to assess the safety, tolerability and evidence of activity of 12 months oral treatment with TEFIDERA® in subjects with Geographic Atrophy associated with Age-Related Macular Degeneration (AMD).
Subthreshold Laser Treatment for Reticular Pseudodrusen Secondary to Age-related Macular Degeneration...
Macular DegenerationSenile4 moreProspective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD. The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy. Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry. The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.