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Found 3 Actively Recruiting clinical trials

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Actively Recruiting

Researchers are exploring new treatment options for neovascular age-related macular degeneration NVAMD, a condition affecting the eyes. This trial aims to compare a new medicine called tiespectus also known as MK-8748 or EYE201 with the standard treatment aflibercept to see if tiespectus works as well in treating NVAMD. The study includes adults aged 50 and older who have not previously received treatment for this condition. Participants will be randomly assigned to one of three groups tiespectus low dose, tiespectus high dose, or aflibercept. Those in the tiespectus groups will receive three initial injections every 4 weeks, followed by injections every 8 weeks up to week 48. After week 48, treatment will continue at intervals based on individual response until week 92. The aflibercept group will receive three initial injections followed by injections every 8 weeks until week 92. During the study, participants will have their vision tested using the Best-Corrected Visual Acuity BCVA score and their eye structure examined with imaging techniques. Researchers will monitor changes in vision over one year and track any side effects up to approximately 96 weeks. Participants will attend regular visits for treatment and assessments throughout the study period lasting about 92 weeks.

Age: 50Years +All GendersPhase 2Phase 3
97 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
P

Actively Recruiting

Researchers are evaluating the effectiveness of ADX-038 compared with a placebo in people aged 60 and older who have geographic atrophy GA caused by age-related macular degeneration AMD. This Phase 2 study also aims to assess the safety, how the body processes the drug pharmacokinetics, and how the drug affects the body pharmacodynamics. Participants will be randomly assigned to receive either the active drug ADX-038, which is a siRNA duplex oligonucleotide, or a saline placebo through subcutaneous treatment. The study follows a parallel design with quadruple masking to compare the effects of the treatments over time. During the study, participants will attend clinic visits for various assessments including imaging to evaluate the preservation of the ellipsoid zone EZ layer in the eye over 12 months. The study team will monitor safety and adherence, and participants must complete meningococcal and pneumococcal vaccinations as required. The total study duration extends until 2030, with the primary outcome measured at 12 months.

Age: 60Years +All GendersPhase 2
35 locations