Ocular Proteomics Testing In Chronic Atrophy | NCT07298291

Studies
Ocular Proteomics Testing In Chronic Atrophy

NCT07298291

Sponsor

ClinOmicsAI

Status

Active, not recruiting

Last Update Posted

May 1, 2026Actual

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Age-Related (Dry) Macular Degeneration

Interventions

AC Tap (anterior chamber paracenthesis)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 30, 2025Actual

Primary Completion Date

Jul 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Dec 1, 2025

First Submission Date that Met QC Criteria

Dec 17, 2025

First Posted Date

Dec 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 30, 2026

Last Update Posted Date

May 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
GA patients	Experimental	Anterior chamber paracentesis (ACP)	Procedure: AC Tap (anterior chamber paracenthesis)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AC Tap (anterior chamber paracenthesis)	Procedure	anterior chamber paracenthesis (microvolume of eye fluid is taken)	GA patients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

89 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Erie Retina Research		Erie	Pennsylvania	16505	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Exploratory study only

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration
D057092	Geographic Atrophy

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided