Palisades Park

Researchers are studying the safety and effectiveness of intravitreal KSI-101 injections in adults with macular edema caused by inflammation, called Macular Edema Secondary to Inflammation MESI. This Phase 3 clinical trial aims to evaluate how well KSI-101 works compared to a sham injection in improving vision for people with this condition. Participants will receive one of three treatments KSI-101 at 5 mg or 10 mg doses injected into the eye every 4 weeks for six months, followed by dosing tailored to individual needs, or a sham injection following the same schedule. The study is randomized, double-masked, and controlled to ensure unbiased results. During the trial, participants will undergo vision tests to measure changes in best-corrected visual acuity BCVA over 24 weeks. Researchers will monitor safety and treatment effects throughout the study. The trial is expected to run until November 2027, with participants receiving regular assessments and follow-ups to track their eye health and response to treatment.

Researchers are conducting a Phase 3 clinical trial to evaluate the safety and effectiveness of intravitreal KSI-101 in adults with macular edema caused by inflammation, known as Macular Edema Secondary to Inflammation MESI. The study aims to understand how well this treatment works compared to a sham injection in improving vision and reducing eye swelling related to this condition. Participants are randomly assigned to receive one of three treatments an intravitreal injection of KSI-101 at either 5 mg or 10 mg doses once every four weeks for six months, followed by personalized dosing schedules, or a sham injection on the same schedule. The injections are given directly into the eye, and the study is double-masked to ensure unbiased results. During the study, participants will undergo regular eye exams to measure visual acuity and eye thickness using specialized imaging. The main outcome is the change in best corrected visual acuity at 24 weeks. Researchers will also monitor the proportion of participants who show improvement in vision over this period. The trial includes safety assessments and will continue until August 2027, with detailed monitoring throughout the treatment and follow-up phases.

Researchers are evaluating KB801, a special virus-based treatment designed to deliver human nerve growth factor to the corneas of people with Stage 2 or 3 neurotrophic keratitis, a condition that affects corneal healing. This Phase 12 study is designed to assess the safety, tolerability, and early signs of effectiveness of KB801 compared to a placebo. The study is double-masked and placebo-controlled, involving participants with persistent corneal epithelial defects that have not improved. Participants will be randomly assigned to receive either KB801 or a placebo, applied topically to the affected eye once daily for 8 weeks. After completing treatment, they will return for a follow-up visit two weeks later to check on safety and the stability of corneal healing. Further safety monitoring will take place every three months for about one year while participants remain in the study. Throughout the trial, participants will undergo regular assessments to monitor safety, including tracking any adverse events. Researchers will evaluate healing of the corneal defects using specific measurements over 8 to 10 weeks. Safety follow-up visits extend through approximately one year to observe the durability of treatment effects and overall tolerability. Participants can expect regular visits for examinations and safety monitoring during this time.

Researchers are evaluating the safety and effectiveness of NEXAGON4 lufepirsen ophthalmic gel in people with persistent corneal epithelial defects PCED, a condition where the corneal surface does not heal properly. This randomized, double-masked, vehicle-controlled study aims to understand how well NEXAGON works in treating PCED and its durability after treatment. This Phase 2 trial is sponsored by Glaukos Corporation and is conducted at multiple centers. Participants will be randomly assigned to receive one of three treatments applied topically to the eye once a week for 4 to 8 weeks a high dose of lufepirsen, a low dose of lufepirsen available only at EU sites, or a vehicle gel without the active drug. After the treatment period, a 4-week follow-up will monitor the condition. If the corneal defect does not heal or the healing is not maintained for 28 days, participants may enter an open-label treatment phase with NEXAGON for an additional 8 weeks. During the study, participants will undergo screening to confirm eligibility, receive weekly treatment applications, and be monitored for safety and healing progress. Researchers will assess corneal re-epithelialization and its durability as the main outcome. The total study participation includes the screening, up to 8 weeks of treatment, 4 weeks of follow-up, and possibly an 8-week open-label extension. Safety, efficacy, and healing durability will be closely observed throughout these periods.

Neurotrophic keratopathy NK is a degenerative eye disease caused by damage to the nerves that supply the cornea, leading to reduced sensitivity and impaired healing of the corneal surface. Researchers are evaluating the safety and effectiveness of a new eye drop solution called 0.1% RGN-259 compared to a placebo for treating this condition. This Phase 3, randomized, multi-center clinical study aims to better understand how well RGN-259 helps heal the cornea in people with NK. Participants will be randomly assigned to receive either the RGN-259 eye drops or a placebo solution. Both treatments are preservative-free, sterile eye drops applied directly into the affected eyes five times daily for 28 days. The RGN-259 contains thymosin beta 4 T4, which is being studied for its potential healing properties, while the placebo has the same ingredients except for T4. The study is double-masked to ensure unbiased results. During the study, participants will have regular assessments including eye examinations, measurements of corneal healing, visual acuity tests, and corneal sensitivity checks using specialized tools. The main outcome measured is the percentage of subjects who achieve complete healing of the persistent epithelial defect by Day 29. Follow-up visits will continue up to Day 43 to monitor changes in lesion size and corneal health. Safety will also be closely monitored throughout the trial, which is expected to end in May 2026.

Researchers are evaluating the safety and tolerability of NOV05, a water-free tacrolimus eye drop solution, in patients with active non-infectious anterior uveitis. This phase 2, randomized, double-masked study aims to test two concentrations of the eye drops over a 6-week treatment period to assess their safety and biological activity. Participants will be randomly assigned to receive either a high dose or a low dose of tacrolimus ophthalmic solution. The treatment is administered four times daily for six weeks. The study is conducted with quadruple masking to ensure unbiased results and is sponsored by Novaliq GmbH. During the study, participants will undergo regular monitoring for adverse events, with the primary outcome measured at 8 weeks. Safety and tolerability will be carefully assessed throughout the treatment period. Participants will be followed closely to evaluate any side effects and the overall biological activity of the treatment.