[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06223048":3,"trial-entities:NCT06223048":117,"trial-summary:NCT06223048":120},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":37,"secondary_outcomes":42,"sex":54,"minimum_age":55,"maximum_age":56,"healthy_volunteers":57,"eligibility_criteria":58,"std_ages":62,"locations":65,"central_contacts":104,"overall_officials":112,"references":115,"see_also_links":116},"NCT06223048","AMDX-2011P-202","A Study of AMDX-2011P in Participants With Primary Open Angle Glaucoma","A Phase 2, Randomized, Open Label Study of AMDX-2011P as a Retinal Tracer in Participants With Primary Open Angle Glaucoma","UNKNOWN","2025-02","2024-07","2024-07-30","2023-12-07","Amydis Inc.","INDUSTRY",true,"The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle Glaucoma (POAG).","This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity of intravenous (IV) doses of AMDX-2011P in participants with POAG. Assessments of retinal images will be conducted by centrally masked assessors.\n\nParticipants will be admitted to the study site where eye examination and retinal imaging will be conducted before administration of the study drug. AMDX-2011P will be administered through a single IV bolus injection followed by safety assessments, retinal imaging, and blood collection and PK.",[19],"Primary Open Angle Glaucoma",[21],"POAG","INTERVENTIONAL","DIAGNOSTIC",[25],"PHASE2",{"count":27,"type":28},50,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"DRUG","AMDX-2011P","AMDX-2011P single bolus injection intravenous for diagnostic review",[35,36],"AMDX-2011P 100 mg","AMDX-2011P 50 mg",[38],{"measure":39,"description":40,"timeFrame":41},"AMDX-2011P Adverse Events Profile","Incidence, nature and severity of AEs\u002FSAEs","8 days",[43,47,50],{"measure":44,"description":45,"timeFrame":46},"Concentration of AMDX-2011P","Plasma PK Concentration (CMax)","2 hours",{"measure":48,"description":49,"timeFrame":46},"Pharmacokinetic Analysis of AMDX-2011P","Area under the plasma versus time curve (AUC)",{"measure":51,"description":52,"timeFrame":53},"Biological Activity","Detection of amyloid deposits in the retina after intravenous AMDX-2011P administration using a conventional retinal fundus fluorescence imaging device.","1 day","ALL","22 Years",null,false,{"inclusion":59,"exclusion":60,"raw_text":61},[],[],"Inclusion Criteria:\n\n1. Diagnosis of primary open angle glaucoma in both eyes\n2. Able to fixate\n3. Glaucomatous optic nerve damage in both eyes, as determined by an investigator as part of an eye exam\n\nExclusion Criteria:\n\n1. Participants unable to read or write\n2. Ocular media is not sufficiently clear to obtain acceptable quality images\n3. Participants with presence of any ocular pathology other than glaucoma in the study eye (cataracts are acceptable)",[63,64],"ADULT","OLDER_ADULT",[66,81,93],{"facility":67,"status":68,"city":69,"state":70,"zip":71,"country":72,"contacts":73,"geoPoint":78},"Associated Retina Consultants","RECRUITING","Phoenix","Arizona","85020","United States",[74],{"name":75,"role":76,"email":77},"Mallory Mintert","CONTACT","mallory.mintert@doctrials.com",{"lat":79,"lon":80},33.44838,-112.07404,{"facility":82,"status":68,"city":83,"state":84,"zip":85,"country":72,"contacts":86,"geoPoint":90},"Global Research Management","Glendale","California","91204",[87],{"name":88,"role":76,"email":89},"Logi El-Harazi","logi@grmclinical.com",{"lat":91,"lon":92},34.14251,-118.25508,{"facility":94,"status":68,"city":95,"state":84,"zip":96,"country":72,"contacts":97,"geoPoint":101},"Eye Research Foundation","Newport Beach","92663",[98],{"name":99,"role":76,"email":100},"Linda Wirta","linda.wirta@drwirta.com",{"lat":102,"lon":103},33.61891,-117.92895,[105,109],{"name":106,"role":76,"phone":107,"email":108},"Joyce Simpauco","858-254-7435","joyce@amydis.com",{"name":110,"role":76,"email":111},"David Bingaman","david.bingaman@amydis.com",[113],{"name":110,"affiliation":13,"role":114},"STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":118,"biomarkers":119},[19],[],{"nct_id":4,"found":15,"summary":121,"prompt_version":131},{"design":122,"status":123,"heading":124,"summary":125,"follow_up":126,"word_count":127,"commitments":128,"compensation":129,"drugs_mentioned":130},"This is an open-label study, meaning you and the study team will know you are receiving AMDX-2011P. However, the people reviewing your eye images won't know which treatment you received. About 50 participants are expected to join.","completed","A Study of AMDX-2011P for Primary Open Angle Glaucoma","This research study is looking at AMDX-2011P, a drug given through an injection into your vein, to see if it can help identify amyloid deposits in the retina (the light-sensitive tissue at the back of your eye) of people with Primary Open Angle Glaucoma (POAG). Researchers want to understand how safe AMDX-2011P is and how your body processes it. You might be able to join if you are 22 years or older, have POAG in both eyes, and your eye doctor has found damage to your optic nerve (the nerve that connects your eye to your brain). The main goal is to track any side effects of AMDX-2011P for 8 days after you receive it. This study is currently recruiting about 50 participants.","Your safety will be monitored for 8 days after receiving the study drug.",123,"You will be admitted to the study site for an eye exam and imaging before receiving a single injection of AMDX-2011P. Afterward, you will have safety checks, more eye imaging, and blood draws.","Not stated in the trial record.",[32],"v2"]