Oak Forest

Researchers are evaluating the safety and effects of a gene therapy called 4D-150 in adults aged 50 years and older with neovascular wet age-related macular degeneration AMD who are currently receiving anti-VEGF treatments and have shown a positive response. This Phase 12 trial includes a dose-escalation stage, a randomized controlled expansion phase, and additional cohorts to optimize steroid use and extend the population studied. The study also includes substudies to assess dosing safety in the opposite eye and to examine vector shedding. Participants receive a single injection of 4D-150 into the eye on Day 1 at assigned dose levels. Some participants receive aflibercept injections as an active comparator. Following the injection, participants are monitored monthly for 24 months to track safety and treatment effects. Those who receive 4D-150 enter a long-term follow-up period lasting up to five years to evaluate extended safety and the duration of the gene therapys activity. The substudies include one-time dosing in the contralateral eye and assessments of vector shedding, with safety monitored for one year and continued follow-up through five years. Throughout the study, participants undergo regular eye function and structure tests, including visual acuity and retinal thickness measurements using imaging technologies. Researchers track adverse events and the need for additional aflibercept injections, as well as changes in vision and retinal health. Participants must comply with study procedures and agree to use barrier methods during and after treatment to prevent fluid transmission. The study ensures comprehensive safety monitoring, with evaluations continuing for up to five years after treatment administration.

Researchers are conducting an observational study to understand the short-term progression of geographic atrophy GA caused by age-related macular degeneration AMD in adults aged 55 years and older. The study aims to identify participants with progressive GA to measure structural and functional changes and explore whether these changes relate to genetic or lifestyle factors. This multi-center research provides insights into disease progression without introducing any treatment interventions. Participants with bilateral GA secondary to AMD will be observed over time. The study involves assessments at baseline, month 3, and month 6 to measure the progression of GA using imaging techniques such as fundus autofluorescence FAF and optical coherence tomography OCT. Researchers will quantify GA lesion size and evaluate visual function parameters, including best-corrected visual acuity BCVA and retinal sensitivity using microperimetry. During the study, participants will attend visits for eye examinations and imaging at specified time points to monitor GA progression. The research team will use these assessments to analyze short-term changes in GA and explore correlations with genetic and lifestyle factors. The total participation duration is approximately six months, during which safety and vision measures will be carefully monitored.

Age-related macular degeneration AMD is an eye condition that causes gradual loss of sharp central vision, making activities like reading or driving difficult. This study focuses on people with geographic atrophy, the advanced stage of dry AMD, where damaged cells in the eye lead to vision loss. Researchers are evaluating ASP7317, a treatment made from human stem cells designed to replace damaged retinal cells and potentially improve vision. This Phase 1b study aims to assess the safety and tolerability of ASP7317 in senior adults with this condition. Participants receive ASP7317 through an injection under the macula after anesthesia, with three different dosage levels low, medium, and high. To reduce the risk of rejection, participants take tacrolimus and other medications before and after the injection to prevent infection. The study has two groups based on vision severitysevere and moderate vision losswith small subgroups receiving escalating doses. A medical panel reviews safety data after each dose before continuing or increasing the dose. Treatment and follow-up visits occur over 52 weeks. During the study, participants attend multiple clinic visits for eye exams, imaging, scans, and blood tests to monitor safety, vision changes, and any side effects. Vital signs such as blood pressure, pulse, and temperature are checked before and after treatment. Researchers track adverse events, graft rejection, and changes in vision and retinal health at set intervals up to one year. Participants may also have additional visits if needed for extra monitoring or care.

Researchers are observing how avacincaptad pegol is used in routine clinical practice for people with geographic atrophy caused by age-related macular degeneration AMD. Geographic atrophy is an advanced form of AMD where retinal cells waste away, leading to worsening central vision and potential permanent vision loss. This observational study collects information on treatment and medical events related to avacincaptad pegol without influencing the doctors treatment decisions. Participants in this study have chosen to begin treatment with avacincaptad pegol, delivered as intravitreal injections into the eye. The study records how often and how long the treatment is given, along with reasons for stopping treatment. It monitors participants receiving this treatment in one or both eyes as part of their regular medical care, without additional interventions from the study. During the study, participants will have eye exams as part of their usual care and will complete surveys about their eye health at the start of treatment, every six months for two years, and then yearly. Researchers will gather data from medical records to track treatment usage, vision changes, and any adverse events for up to about five years. This long-term observation helps understand real-world treatment patterns and safety.

Researchers are evaluating a gene therapy called Ixoberogene Soroparvovec Ixo-vec for people with neovascular wet age-related macular degeneration nAMD, a condition that causes abnormal blood vessel growth in the retina and can lead to vision loss, especially in adults over 65. This Phase 3, randomized, double-masked study compares the effects of a single injection of Ixo-vec to the standard treatment aflibercept. The study aims to assess whether Ixo-vec is not less effective than aflibercept in improving vision, measured by changes in best corrected visual acuity BCVA at one year. Participants are assigned to one of two groups one receives three monthly aflibercept injections followed by a single Ixo-vec injection and sham injections every eight weeks the other group receives three monthly aflibercept injections, a sham injection at week one, and aflibercept every eight weeks. Treatments are delivered through intravitreal injections directly into the eye. Safety, tolerability, and vision outcomes will be closely monitored throughout the study period. During the study, participants will undergo regular eye exams to measure visual acuity and retinal health using various imaging techniques and questionnaires assessing vision-related quality of life. Researchers will track the number of aflibercept injections needed, changes in retinal thickness, and the presence of fluid in the retina. The study lasts at least 56 weeks, with key vision measurements taken at weeks 52 and 56. Safety assessments for ocular and non-ocular adverse events will also be conducted. Participants must be at least 50 years old and have active nAMD in the study eye to join.

Researchers are evaluating the long-term safety and tolerability of the Port Delivery System with ranibizumab PDS in people with neovascular age-related macular degeneration nAMD. This study includes participants who have completed earlier related studies or met specific criteria in a recent study. Two sub-studies are included one assessing the use of transscleral photocoagulation TPC to reduce vitreous hemorrhages after PDS implantation, and another evaluating the safety of re-implanting an updated PDS device. Participants will receive PDS implants and undergo refill-exchanges of ranibizumab at various intervals, mostly every 24 weeks Q24W, with some switching to every 12 weeks Q12W visits later in the study. The transscleral photocoagulation sub-study involves PDS implantation using TPC followed by ranibizumab refills. The re-implantation sub-study includes follow-up for up to 72 weeks after receiving the updated implant and scheduled refill-exchanges. During the study, participants will attend scheduled visits for treatment and assessments lasting up to several years. Researchers will monitor ocular and systemic adverse events, focusing on the severity and duration of side effects related to the device and treatment. Vision and eye health will be regularly evaluated using tests like best-corrected visual acuity and imaging. Safety data from the sub-studies will also be collected, including rates of vitreous hemorrhage and other ocular events, with study participation extending until regulatory decisions or study closure.

Researchers are evaluating the safety and effectiveness of a single intravitreal injection of 4D-150 in adults aged 50 and older with macular neovascularization caused by neovascular age-related macular degeneration nAMD. This Phase 3 trial compares 4D-150 to an active control treatment, aflibercept, to better understand how these treatments affect vision and eye health in this condition. Participants are randomly assigned to receive either one dose of 4D-150 or aflibercept injections at scheduled visits. The 4D-150 is given as a single intravitreal injection on Day 1, while aflibercept is administered during follow-up visits as needed. The study includes a 52-week period to assess visual changes and a longer 104-week period to monitor the need for additional aflibercept injections and other eye health measures. During the study, participants will undergo eye exams including measurements of visual acuity using the ETDRS letter score and evaluations of the central subfield thickness in the retina. Researchers will track the number and timing of aflibercept injections and monitor any anatomical or functional changes in the treated eye. Safety and stability of vision will be observed throughout the trial period, which lasts up to two years.

Diabetic Retinopathy DR is a common eye condition caused by diabetes that damages blood vessels in the retina, potentially leading to vision problems or blindness if untreated. This trial evaluates surabgene lomparvovec sura-vec, a one-time gene therapy injected into the suprachoroidal space SCS, for adults with non-proliferative DR NPDR without center-involved diabetic macular edema CI-DME. The study includes Phase 2b, Phase 3, and a bilateral treatment portion, enrolling about 576 adult participants in the United States and Puerto Rico. Participants are randomized to receive either a single SCS injection of sura-vec with prophylactic steroids or a sham injection with artificial tears in one eye during the Phase 2b and Phase 3 portions. Those assigned to sham may later cross over to receive sura-vec. In the bilateral treatment portion, participants receive sura-vec and steroids in both eyes. Follow-up for all participants continues for up to five years after treatment to monitor effects and safety. During the study, participants attend regular clinic visits for medical assessments including vision tests, blood tests, and safety monitoring. Researchers evaluate vision changes using the Diabetic Retinopathy Severity Scale DRSS, track vision-threatening events, and monitor for side effects such as ocular inflammation. Questionnaires are also completed to assess participant experience. The study aims to measure improvements in diabetic retinopathy severity and the occurrence of adverse events over time.