Lemont

Researchers are investigating new treatments for neovascular age-related macular degeneration NVAMD, a condition that affects vision. This study aims to learn if a medicine called tiespectus also known as MK-8748 or EYE201 can treat NVAMD as well as the standard treatment called aflibercept. The trial is a pivotal Phase 23 study that compares these treatments in people newly diagnosed with NVAMD. Participants are randomly assigned to one of three groups one group receives a low dose of tiespectus, another receives a high dose of tiespectus, and the third group receives aflibercept. Those in the tiespectus groups get three initial injections every 4 weeks, then continue injections every 8 weeks until week 48, followed by treatments at intervals based on their individual response up to week 92. The aflibercept group receives three initial injections followed by injections every 8 weeks until week 92. During the study, participants are regularly assessed for changes in their best-corrected visual acuity using ETDRS letters from baseline to one year. Other evaluations include eye imaging to measure retinal thickness and monitoring for any adverse events up to approximately 96 weeks. The study lasts over one year with ongoing visits to track treatment response and safety.

This research investigates intravitreal EYE103 in adults with neovascular age-related macular degeneration NVAMD or macular edema caused by branch retinal vein occlusion BRVO. The trial is randomized and dose-masked, including four different patient groups to study different doses and combinations of EYE103, aiming to assess its effects in these eye conditions. Participants are divided into four cohorts treatment-naive NVAMD, incomplete responders IR with NVAMD as monotherapy, IR NVAMD combined with aflibercept, and treatment-naive BRVO. Each cohort randomly receives either a low or high dose of EYE103 via intravitreal injection. All receive three injections spaced 4 weeks apart the IR NVAMD combination group also receives aflibercept on Day 1. Assessments occur at each injection visit and some groups return 2 weeks post-injection for extra evaluations. During the 12-week study, participants undergo safety and efficacy assessments including vision tests using ETDRS charts, slit-lamp exams, fundoscopy, and imaging with spectral domain optical coherence tomography SD-OCT to measure retinal thickness. The studys main measure is the change in best-corrected visual acuity at Week 12. The trial also monitors retinal thickness and vision changes throughout. The Week 12 visit marks the studys end for all participants.

Researchers are evaluating the long-term safety and tolerability of JNJ-81201887, given as an intravitreal injection a shot into the eye, in participants with Geographic Atrophy GA secondary to Age-related Macular Degeneration AMD. This study is a long-term extension of parent clinical trials where participants had previously received either low or high doses of JNJ-81201887 or a sham procedure. The goal is to monitor participants over an extended period to understand any lasting treatment effects or side effects. Participants entering this long-term extension study will not receive additional doses of the study drug or any new intervention as part of this trial. They previously participated in parent studies where they were treated with either low dose or high dose JNJ-81201887 or sham procedure. Some participants who were in the sham group of the parent study may receive open-label treatment outside this study before entering this extension. This study focuses solely on follow-up without new treatment administration. Throughout the study, participants will undergo regular assessments to monitor ocular and systemic safety. These include tracking treatment-emergent adverse events, clinical laboratory tests, retinal imaging, and eye examinations over up to five years. This extended monitoring aims to evaluate the long-term safety profile of the previous treatments. Participants will be followed with periodic visits and evaluations, with the total study duration extending until 2030.

Researchers are conducting a Phase IIb randomized clinical trial to evaluate the safety and effects of the CPCB-RPE1 implant in people with geographic atrophy involving the fovea, a form of advanced dry age-related macular degeneration AMD. This study aims to better understand how this subretinal implant may impact retinal sensitivity and visual acuity in affected individuals. Participants will be randomly assigned in a 31 ratio to receive either the surgical implantation of the CPCB-RPE1 device or a simulated sham implantation procedure. Up to 24 subjects across multiple centers will participate, with up to 18 receiving the active implant and up to 6 undergoing the sham surgery. The implant is placed under the retina through a surgical approach, and the control group receives a procedure mimicking surgery without implant placement. During the study, participants will undergo baseline and follow-up retinal sensitivity testing and visual acuity assessments, with primary outcomes measured one year after implantation. Researchers will monitor safety and efficacy throughout the study, including the ability of participants to complete microperimetry testing and post-operative care. The study will continue until December 2040, covering the screening, treatment, and outcome evaluation periods.

Researchers are evaluating the safety, tolerability, and effectiveness of a one-time intravitreal injection of SAR446597 in people with Geographic Atrophy GA caused by Age-related Macular Degeneration AMD. This sequential Phase 12 study includes two parts and will take place at multiple centers. The study aims to learn how well this treatment works and how safe it is for participants with this eye condition. Participants will receive a single intravitreal injection of SAR446597, with different dose levels tested across successive groups in Part I. In Part II, participants may receive SAR446597 at one of two dose levels or a sham injection as a control. The core study phase lasts about 2 years per participant, followed by an additional 3-year Extended Follow-Up phase to monitor long-term effects. Throughout the study, participants will undergo regular assessments including eye exams to measure changes in the size of GA lesions and visual acuity using standardized charts. Safety will be monitored closely by tracking any treatment-related adverse events. The total participation time spans approximately 5 years, allowing researchers to evaluate both short- and long-term outcomes of SAR446597 treatment.

The trial investigates the corneal endothelial cells in adults aged 50 and older with neovascular age-related macular degeneration nAMD who are treated with the Port Delivery System PDS implant delivering ranibizumab. This Phase IV, open-label study aims to monitor changes in corneal endothelial cell density over time, comparing the treated eye with the fellow eye to evaluate the effects of this device-based treatment approach. Participants will have a PDS implant surgically inserted in the study eye, initially filled with ranibizumab before implantation. Following this, the implant will be refilled every 24 weeks. Supplemental intravitreal ranibizumab injections may be given if the participant stops study treatment, based on investigator discretion. The study monitors participants for at least 48 weeks, focusing on corneal cell changes and ocular safety events. During the study, participants undergo assessments including specular microscopy to measure corneal endothelial cell density and morphology at baseline and at weeks 24 and 48. Researchers will track ocular adverse events, device-related effects, and serious safety concerns throughout the approximately one-year follow-up. The study collects visual acuity data, imaging results, and historical treatment records to support evaluation. Participants remain under close observation to assess treatment impact and safety.

Researchers are evaluating the experimental drugs pozelimab and cemdisiran for treating Geographic Atrophy GA, a late stage of Age-related Macular Degeneration AMD that affects central vision. The study aims to compare the progression rate of GA in patients receiving cemdisiran alone, the combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring side effects, drug levels in the blood over time, and the bodys antibody response to these drugs. Participants will receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized and double-masked with three groups receiving different treatments. Treatment and monitoring will continue through specified time points up to 104 weeks, with follow-up on safety and antibody responses extending even further. During the study, participants will attend regular clinic visits for eye exams, imaging using Fundus Autofluorescence to measure GA lesion growth, vision tests including visual acuity and contrast sensitivity, and blood tests to assess drug levels and antibody formation. Researchers will track treatment-emergent adverse events and evaluate changes in vision and GA progression over time. Participation lasts until the study completion date in April 2033, with primary outcomes assessed at 52 weeks and further evaluations up to 296 weeks.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effects of EYP-1901 against Aflibercept in patients with diabetic macular edema DME, a condition related to diabetic retinopathy. The study aims to evaluate the treatments impact on vision improvement, with a focus on the average change in best-corrected visual acuity BCVA over one year. Participants are assigned to receive either EYP-1901 or Aflibercept, both delivered by intravitreal injection directly into the eye. The study uses a parallel group design with random allocation and masking to compare these two drug treatments. The primary measurement is taken at weeks 52 and 56, with secondary outcomes including the rate of injection burden by week 56. During the study, participants will undergo regular vision assessments using the ETDRS letter score. Researchers will monitor treatment effects and safety throughout the trial period, which extends until October 2028. The total participation time includes screening, treatment, and follow-up visits designed to evaluate vision changes and treatment needs over approximately one year.

Researchers are evaluating the safety, tolerability, and effectiveness of a gene therapy called Ixo-vec Ixoberogene soroparvovec in adults aged 50 years and older who have bilateral neovascular wet age-related macular degeneration nAMD. This Phase 2, single-arm, open-label study focuses on treating the second eye contralateral eye with Ixo-vec, including participants who have previously received the therapy in one eye and those receiving it for the first time. The study aims to understand how well the treatment works and how long its effects last when both eyes are treated at different times. Participants will receive a single intravitreal injection of Ixo-vec in the contralateral eye. The study includes both participants experienced with Ixo-vec and those who are treatment-nave, with dosing designed to evaluate safety and clinical activity including visual and anatomical outcomes. The treatments durability will be assessed over time, along with the need for additional anti-VEGF therapy. The study does not involve a placebo or comparator group and is conducted across multiple centers. During the study, participants will be followed for approximately 5 years to monitor safety, including ocular and non-ocular adverse events, and to evaluate visual acuity and retinal thickness changes. Researchers will also track supplemental aflibercept injections required after treatment. Participants will undergo regular assessments of vision and eye health, and adherence to study procedures will be monitored throughout. The long follow-up period allows evaluation of the gene therapys lasting effects and safety profile in bilateral treatment of nAMD.

Researchers are evaluating the safety and effectiveness of the i-Lumen AMD transpalpebral microcurrent device and therapy in people with intermediate to advanced nonexudative age-related macular degeneration AMD. This clinical device trial is randomized, sham-controlled, and double-masked to compare active microcurrent therapy with a sham treatment. The study is designed to better understand how this device may affect vision in this patient group. Participants will start with an initial loading phase of the i-Lumen AMD therapy, followed by seven maintenance treatments over about 11 months. The treatments involve using the transpalpebral microcurrent stimulation system applied near the eye. There is a comparison between active therapy and a sham placebo-like therapy to assess differences in outcomes. After completing treatments, participants will have monthly visits through Month 14, which is three months after the last treatment, for monitoring and evaluation. During the study, participants will have their vision assessed regularly, focusing on best-corrected visual acuity BCVA changes from baseline at 3 months as the primary outcome. Other measures include the portion of eyes responding to treatment and BCVA changes at 6 months. Monthly visits allow for ongoing safety monitoring and effectiveness assessments. Total participation lasts over a year, including treatment and follow-up periods, to observe any lasting effects or changes in vision.