Ocular Proteomics Testing In Chronic Atrophy (OPTICA)

April 30, 2026 updated by: ClinOmicsAI

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)

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16505
        • Erie Retina Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GA patients
Anterior chamber paracentesis (ACP)
Procedure: AC Tap (anterior chamber paracenthesis)
anterior chamber paracenthesis (microvolume of eye fluid is taken)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-Emergent Adverse Events
Time Frame: From enrollment to end of Visit 2
Incidence of Treatment-Emergent Adverse Events
From enrollment to end of Visit 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline (Day 0) to Month 1 (Day 30)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ClinOmicsAI

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

December 30, 2026

Study Registration Dates

First Submitted

December 1, 2025

First Submitted That Met QC Criteria

December 17, 2025

First Posted (Actual)

December 23, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 30, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COAI-OPTICA-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Exploratory study only

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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