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Found 5 Actively Recruiting clinical trials

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Actively Recruiting

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.

Age: 18Years +All GendersPhase 2
49 locations
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Actively Recruiting

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.

Age: 60Years +All GendersPhase 2
104 locations
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Actively Recruiting

Researchers are evaluating how well different doses of a medicine called BI 3812465 are tolerated in adults with diabetic macular edema that affects the center of the eye. This is the first time BI 3812465 is being given to humans. The study is a Phase IIIa trial conducted in two parts to investigate safety and tolerability of this treatment. In Part 1, a small group of participants receive low, medium, or high doses of BI 3812465 as injections into the back of the eye. Participants starting later receive higher doses only if lower doses are tolerated. In Part 2, a larger group is randomized into low, medium, or high dose groups, also receiving three eye injections of BI 3812465. The treatment is given sequentially with dose escalation based on safety. Participants stay in the study for up to seven months, attending 19 visits to the study site, with some visits possibly conducted at home. During these visits, doctors assess the severity of the eye condition and monitor any health problems related to the treatment. The study measures safety outcomes including dose limiting events and ocular adverse events over up to 169 days after treatment starts.

Age: 18Years +All GendersPhase 1Phase 2
30 locations
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Actively Recruiting

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.

Age: 18Years +All GendersPhase 3
70 locations
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Actively Recruiting

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.

Age: 50Years +All GendersPhase 3
94 locations