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

Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA)

The primary objective of this study is to assess the safety and tolerability of serial (two) AC paracentesis procedures, performed at Baseline and Month 1, for the collection of AH in subjects with Geographic Atrophy (GA) or dry Age-Related Macular Degeneration (dAMD).

Inclusion Criteria:

• 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 Criteria:

• 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.