Schertz

Researchers are evaluating the effectiveness, safety, tolerability, and pharmacodynamics of multiple doses of APL-3007 combined with Syfovre/Pegcetacoplan (APL-2) in patients aged 60 years and older diagnosed with geographic atrophy secondary to age-related macular degeneration. This Phase 2, randomized, placebo-controlled, multicenter, masked study focuses on measuring changes in retinal pigment epithelium lesions using advanced artificial intelligence-based SD-OCT imaging. Participants will receive either the combination of APL-3007 with pegcetacoplan (APL-2) or a placebo. The study includes a treatment period with multiple doses administered, aiming to assess the impact on geographic atrophy lesions over a 12-month period. Syfovre injections at 6-8 week intervals prior to enrollment are part of the inclusion criteria. During the study, participants will undergo various eye imaging assessments such as OCT and FAF to monitor lesion size and progression. Researchers will evaluate changes in lesions at month 12 compared to baseline. Safety and tolerability will be closely monitored through laboratory tests, clinical evaluations, and vaccination status requirements. The study duration includes regular visits for treatment administration and monitoring over at least one year.

Researchers are evaluating corneal endothelial cells in people aged 50 and older who have neovascular age-related macular degeneration (nAMD). The study focuses on participants treated with the Port Delivery System (PDS) refilled every 24 weeks. This Phase IV, open-label trial aims to understand changes in corneal endothelial cell density over time in the eye receiving treatment compared to the fellow eye. The study involves delivering ranibizumab 100 mg/mL via the PDS implant. Supplemental treatment with intravitreal injections of ranibizumab (0.5 mg of a 10 mg/mL formulation) in the study eye may be given if needed. If participants stop the study treatment, they may receive intravitreal ranibizumab injections based on the investigator's judgment. Treatment and monitoring occur over at least 48 weeks. Participants will undergo detailed eye examinations including specular microscopy to measure corneal endothelial cell density at baseline and week 48. Historical visual acuity and imaging data will be reviewed. Researchers will monitor safety, disease activity, and treatment response through visual acuity assessments, optical coherence tomography, and other imaging techniques. The main outcome is the percent change in corneal endothelial cell density in the treated eye compared to the fellow eye after 48 weeks.

Researchers are evaluating the effectiveness of EYP-1901 compared to Aflibercept in treating people with diabetic macular edema (DME), a condition related to diabetic retinopathy that affects vision. This is a phase 3, randomized, double-masked study designed to compare these two treatments. The study focuses on participants who have either been treated before or are new to treatment with documented macular edema due to diabetic retinopathy. Participants will receive either EYP-1901 or Aflibercept through intravitreal injections, which involve injecting the drug directly into the eye. The study is designed to be double-masked, meaning neither participants nor researchers know which treatment is being given, to fairly assess the effects of each drug. The treatments are given during the study period, with careful monitoring of vision changes. During the study, participants will have their best-corrected visual acuity (BCVA) measured using standardized eye charts at weeks 52 and 56 to observe changes in their vision. Researchers will monitor the participants closely to evaluate safety and effectiveness throughout the study. The total duration for participants includes screening, treatment, and follow-up assessments to ensure comprehensive evaluation of the treatments.

Researchers are evaluating the safety and effectiveness of Ixoberogene Soroparvovec (Ixo-vec) for treating neovascular (wet) age-related macular degeneration (nAMD) in adults aged 50 years and older. This Phase 3, multi-center, randomized, double-masked study compares a single intravitreal injection of Ixo-vec with an active comparator, Aflibercept. The study focuses on a broad population including both treatment-naïve and treatment-experienced participants, aiming to assess if Ixo-vec is not less effective than the comparator in improving vision. Participants will receive one intravitreal injection of either Ixo-vec or Aflibercept. Ixo-vec is a gene therapy designed to reduce the treatment burden by potentially decreasing the need for frequent injections that are common in current anti-VEGF treatments for nAMD. The study includes a screening period followed by treatment administration and ongoing safety and efficacy assessments. During the study, participants will undergo regular evaluations including measurements of best corrected visual acuity (BCVA) at baseline and at Weeks 52 and 56 to monitor changes in vision. Safety, tolerability, and treatment response will be closely observed throughout the study duration. Researchers will also monitor anatomical responses to therapy and overall eye health through clinical assessments and adherence to eye drop use as required by the protocol.

Researchers are investigating the safety and effectiveness of a gene therapy called Ixo-vec in people aged 50 and older 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. This Phase 3, multi-center, randomized, double-masked study compares a single injection of Ixo-vec with the standard treatment of intravitreal aflibercept. The main goal is to see if Ixo-vec is not worse than aflibercept in improving best corrected visual acuity (BCVA) at one year after treatment. Participants will receive one intravitreal injection of either Ixo-vec or aflibercept in the affected eye. Ixo-vec is delivered as a gene therapy designed to reduce the need for frequent anti-VEGF injections, while aflibercept is an active drug comparator given intravitreally. The study includes a screening period and treatment followed by assessment visits, with the primary efficacy measurement taken as an average of BCVA changes at Weeks 52 and 56. Throughout the study, participants will undergo regular eye exams, visual acuity tests, and safety monitoring to evaluate how well the treatments work and their tolerability. Researchers will track changes in vision and any side effects from the treatments. The study is designed to assess both short-term and longer-term outcomes related to vision and safety, with total participation lasting over one year including screening and follow-up visits.