Lemont

Researchers are investigating new treatment options for neovascular age-related macular degeneration (NVAMD), a condition affecting the eyes. Standard treatments like aflibercept do not work for everyone, so this trial is studying a medicine called tiespectus (also known as MK-8748 or EYE201) to see if it can effectively treat NVAMD. This is a pivotal Phase 2/3 randomized, double-masked, multicenter study comparing tiespectus to aflibercept. Participants will receive treatment by intravitreal injection directly into the eye. The study has three groups: one receiving tiespectus, another receiving aflibercept (2 mg), and possibly a third comparator group as part of the design. The study aims to assess the efficacy and safety of these treatments in people newly diagnosed with NVAMD. During the study, participants will be monitored for changes in their best-corrected visual acuity (BCVA) using standard eye charts from the start of the study to one year later. Researchers will perform regular eye exams and safety assessments to track treatment effects. Participation involves follow-up visits over at least one year to evaluate vision changes and treatment safety in detail.

Researchers are evaluating intravitreal EYE103 in participants with neovascular age-related macular degeneration (NVAMD) or macular edema following branch retinal vein occlusion (BRVO). This Phase 2, randomized, dose-masked study includes four patient cohorts: treatment-naive NVAMD participants, incomplete responder (IR) NVAMD participants as monotherapy, IR NVAMD participants receiving EYE103 combined with aflibercept 2.0 mg, and treatment-naive BRVO participants. The study aims to assess safety and efficacy of different doses of EYE103 in these conditions. Participants in each cohort will be randomly assigned to receive either a low or high dose of EYE103 via intravitreal injection. All participants will receive three injections spaced four weeks apart. IR NVAMD participants in the combination therapy cohort will also receive an injection of aflibercept 2.0 mg on Day 1. The timing of enrollment into each cohort is determined by the Sponsor. Participants will undergo safety and efficacy assessments at each injection visit, with some cohorts returning two weeks after injections for further evaluations. Assessments include measuring best-corrected visual acuity using the ETDRS chart, slit-lamp biomicroscopy, fundoscopy, and spectral domain optical coherence tomography (SD-OCT) to measure central subfield thickness. The study concludes at Week 12, which is the end-of-study visit for all participants.

The purpose of this study is to assess the long-term safety and tolerability after an intravitreal injection (a shot of medicine into the eye) of JNJ-81201887 administered in parent clinical studies.

Researchers are conducting a Phase IIb randomized clinical trial to evaluate the safety and effectiveness of the CPCB-RPE1 implant in people with advanced dry age-related macular degeneration (AMD) who have geographic atrophy affecting the fovea. The trial aims to compare outcomes between those receiving the implant and those undergoing a simulated sham procedure. This study involves multiple surgical implantation sites and may include additional referral or follow-up locations. Participants will be randomly assigned in a 3:1 ratio to either receive the CPCB-RPE1 implant through a surgical procedure or to a control group receiving a sham implantation. Up to 18 participants will receive the implant, and up to 6 will be in the control group. The implant is surgically placed under the retina using a pars plana vitrectomy technique. Participants must be pseudophakic in the study eye and medically fit for surgery and anesthesia. During the study, participants will undergo baseline and follow-up retinal sensitivity testing using microperimetry to assess changes over one year after implantation. Researchers will monitor visual acuity, retinal sensitivity, and safety outcomes throughout the study. Participants must be able to attend all required visits and complete the assessments, including microperimetry testing and providing informed consent. The total participation duration includes screening, treatment, and follow-up evaluations.

This research evaluates the safety, tolerability, and effectiveness of a single intravitreal injection of SAR446597 in people with Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD). It is a Phase 1/2, two-part, multicenter study focusing on participants aged 60 years and older who have this eye condition. The study aims to assess the impact of this treatment on GA over a long period. Participants receive a one-time injection of SAR446597 directly into the eye, or a sham injection during Part II of the study. The core study phase lasts about two years for each participant, followed by an Extended Follow-Up (EFU) phase that continues for three more years to monitor long-term safety and effects. During the study, researchers monitor for ocular and non-ocular treatment-emergent adverse events and serious adverse events from Day 1 through Week 104. Participants undergo regular assessments of their eye health and vision, including visual acuity and lesion size evaluations. The total participation includes the core phase and extended follow-up, ensuring thorough observation of treatment safety and tolerability over five years.

Researchers are studying the safety and effectiveness of a single-dose intravitreal injection of SAR402663 in adults aged 50 to 90 with neovascular age-related macular degeneration (nAMD). This Phase 1/2 multicenter trial includes two parts: a dose escalation phase to test multiple dose levels, followed by a dose expansion phase where participants receive one of two dose levels chosen from initial results. The study aims to evaluate how well SAR402663 works and how safe it is for this eye condition. Participants will receive a one-time injection of SAR402663 into one eye. In the first part, different doses will be tested in groups of participants. In the second part, participants will be randomly assigned to one of two doses, with neither participants nor researchers knowing which dose is given. After the injection, participants will be regularly checked for 12 months, then enter an extended follow-up phase lasting up to 5 years to monitor long-term safety and effects. Throughout the study, participants will have regular assessments including eye exams, vision tests, laboratory tests, and monitoring for any side effects both related to the eye and the rest of the body. Researchers will track the number and severity of any treatment-related adverse events and changes in vital signs or lab results over the full year. The extended follow-up will assess the durability of the treatment's effects and long-term safety.

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 studying the effects of two experimental drugs, pozelimab and cemdisiran, in adults aged 50 to 85 who have Geographic Atrophy (GA) caused by Age-related Macular Degeneration (AMD), a condition that affects central vision. The study aims to compare how quickly GA progresses in patients treated with cemdisiran alone, a combination of pozelimab and cemdisiran, or a placebo. Additional goals include monitoring possible side effects, measuring drug levels in the blood, and checking for antibodies that might reduce drug effectiveness or cause side effects. Participants receive subcutaneous injections of either pozelimab combined with cemdisiran, cemdisiran alone, or a placebo. The study is randomized, double-masked, and placebo-controlled, conducted at multiple centers. Treatment schedules and dosing are managed as described in the protocol, with vaccinations for meningococcal and pneumococcal infections required prior to participation. Throughout the study, participants undergo regular clinic visits where eye imaging using Fundus Autofluorescence (FAF) tracks the progression of GA lesion area over 52 weeks. Researchers also monitor safety, side effects, and immune responses, ensuring adherence to study procedures. The main outcome measured is the growth rate of the GA lesion area over one year, helping to evaluate the potential benefits and risks of the study drugs.

Researchers are evaluating the effectiveness, safety, and pharmacokinetics of the Port Delivery System (PDS) with ranibizumab compared to standard intravitreal ranibizumab injections in adults with diabetic macular edema (DME). This Phase III, multicenter, randomized study aims to compare PDS treatment every 24 weeks with injections every 4 weeks. A substudy will assess the safety of re-implanting the updated PDS and performing refill-exchange procedures in participants previously enrolled in the main study. Participants will receive either the PDS implant pre-filled with ranibizumab or intravitreal ranibizumab injections according to their assigned group. Treatments will be administered on a set schedule specific to each arm. The substudy involves re-implantation of the updated PDS and monitoring post-procedure. The PDS refill exchange is also part of the treatment plan for some participants. Throughout the study, participants will undergo assessments including vision tests using the ETDRS chart to measure changes in best-corrected visual acuity (BCVA). Safety will be monitored by tracking ocular and systemic adverse events, device-related effects, and any serious complications up to 72 weeks after treatment or re-implantation. The study evaluates both short-term and long-term safety and efficacy outcomes over the full duration of participation.

Researchers are conducting a phase 3 randomized, double-masked study to compare the effectiveness of EYP-1901 with Aflibercept in people with diabetic macular edema (DME). The study focuses on patients who have either been treated before or are new to treatment for macular edema related to diabetic retinopathy. The goal is to evaluate how well these treatments improve vision in affected eyes over time. Participants will receive either EYP-1901 or Aflibercept through injections into the eye. Both treatments are given as intravitreal injections, meaning they are injected directly into the eye. The study design ensures that neither the participants nor the researchers know which treatment each participant receives, maintaining a double-masked approach to reduce bias. During the study, researchers will monitor changes in the participants' best-corrected visual acuity (BCVA) at weeks 52 and 56 to assess treatment effects. Participants' vision will be carefully measured using standardized eye charts. The total duration and detailed schedule of visits and assessments are guided by the study protocol to ensure thorough evaluation of each treatment's impact on diabetic macular edema.