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Active, Not Recruiting

NCT Number: NCT07298291

Ocular Proteomics Testing In Chronic Atrophy

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age-Related (Dry) Macular Degeneration Eye Diseases Geographic Atrophy Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

50 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erie Retina Research

Erie, Pennsylvania, 16505, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AC Tap (anterior chamber paracenthesis)

Procedure

anterior chamber paracenthesis (microvolume of eye fluid is taken)

Primary outcomes

  1. Incidence of Treatment-Emergent Adverse Events

    Time frame: From enrollment to end of Visit 2

    Incidence of Treatment-Emergent Adverse Events

Secondary outcomes

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

    Time frame: From Baseline (Day 0) to 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.

Sponsors and collaborators

Lead sponsor

ClinOmicsAI

Network

Registry information

Official study title

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

Acronym: OPTICA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 23, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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