Ocular Proteomics Testing In Chronic Atrophy

ClinOmicsAI50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Age-Related (Dry) Macular Degeneration

Interventions

AC Tap (anterior chamber paracenthesis)PROCEDURE

anterior chamber paracenthesis (microvolume of eye fluid is taken)

Eligibility

Sex: ALLMin age: 50 YearsMax age: 89 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Erie Retina Research

Erie, Pennsylvania, United States

RECRUITING

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events

Time frame: From enrollment to end of Visit 2

Secondary Outcomes

Longitudinal changes in the Aqueous Humor proteome between Baseline (Day 0) and Month 1 (Day 30)

The secondary objective of this study is to characterize longitudinal changes in the AH proteome between Baseline (Day 0) and Month 1 (Day 30) by analyzing AH specimens collected at these two time points.

Time frame: From Baseline (Day 0) to Month 1 (Day 30)

Central Contacts

BRUNO GAGNON, BPharm MSc

CONTACT

14152467106 bgagnon@casexerie.com

Data from ClinicalTrials.gov

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