Ocular Proteomics Testing In Chronic Atrophy

NCT ID: NCT07298291

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-30

Study Completion Date

2026-07-30

Brief Summary

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

Detailed Description

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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).

Conditions

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Age-Related (Dry) Macular Degeneration

Keywords

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geographic atrophy AMD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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GA patients

Anterior chamber paracentesis (ACP)

Group Type EXPERIMENTAL

AC Tap (anterior chamber paracenthesis)

Intervention Type PROCEDURE

anterior chamber paracenthesis (microvolume of eye fluid is taken)

Interventions

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AC Tap (anterior chamber paracenthesis)

anterior chamber paracenthesis (microvolume of eye fluid is taken)

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ClinOmicsAI

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Erie Retina Research

Erie, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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BRUNO GAGNON, BPharm MSc

Role: CONTACT

Phone: 14152467106

Email: [email protected]

Facility Contacts

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Bethany Scott

Role: primary

Other Identifiers

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COAI-OPTICA-001

Identifier Type: -

Identifier Source: org_study_id