RecruitingNot ApplicableNCT07298291
Ocular Proteomics Testing In Chronic Atrophy
A Phase 1, Single-Center, Prospective Study to Evaluate the Safety and Clinical Utility of Anterior Chamber Paracentesis for Proteomic Analysis in Patients With Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration
Sponsor
ClinOmicsAI
Enrollment
50 participants
Start Date
Nov 30, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA)
Eligibility
Min Age: 50 YearsMax Age: 89 Years
Inclusion Criteria5
- Male or female subjects aged between 50 and 89 years, inclusive
- For the GA cohort: Clinical diagnosis of GA secondary to AMD or dAMD in the study eye, confirmed by fundus autofluorescence imaging and spectral-domain optical coherence tomography (SD-OCT).
- For the control cohort: No clinical evidence of retinal disease in either eye.
- Best-corrected visual acuity (BCVA) of ≥20/200 in the study eye, as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) charts
- Ability and willingness to provide written informed consent before any study-specific procedures.
Exclusion Criteria6
- Presence of active ocular infection or inflammation in either eye at the time of screening.
- History of intraocular surgery in the study eye within the three months preceding enrollment.
- Intraocular pressure (IOP) greater than 21 mmHg in the study eye at screening
- Use of systemic anticoagulation therapy that cannot be safely discontinued prior to ACP.
- Pregnant or nursing women.
- Known hypersensitivity or contraindication to any of the medications or procedures used in the study.
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Interventions
PROCEDUREAC Tap (anterior chamber paracenthesis)
anterior chamber paracenthesis (microvolume of eye fluid is taken)
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07298291