Age-Related (Dry) Macular DegenerationOPTICANCT07298291
Ocular Proteomics Testing In Chronic Atrophy
A study testing AC Tap (anterior chamber paracenthesis) in people with Age-Related (Dry) Macular Degeneration, run by ClinOmicsAI at 1 site in United States.
Trial summary
Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA) Read more about this study
- Who is it for?
- Ages 50 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related (Dry) Macular Degeneration
- What is being tested?
- AC Tap (anterior chamber paracenthesis)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
Study to evaluate the safety of routine diagnostic anterior chamber paracentesis (ACP) for proteomic profiling in patients with geographic atrophy (GA)
Read the 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).
- Conditions
- Age-Related (Dry) Macular Degeneration
- Being tested
- AC Tap (anterior chamber paracenthesis)
- Keywords
- geographic atrophy, AMD
- Medical subject headings
- Macular Degeneration, Geographic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AC Tap (anterior chamber paracenthesis)Procedure or surgery
anterior chamber paracenthesis (microvolume of eye fluid is taken)
| Study group | Role | What they receive |
|---|---|---|
| GA patients | Experimental | Anterior chamber paracentesis (ACP) Receives: Procedure: AC Tap (anterior chamber paracenthesis) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events
Measured: From enrollment to end of Visit 2
Secondary outcomes (1)
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.
Measured: From Baseline (Day 0) to Month 1 (Day 30)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start30 Nov 2025
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related (Dry) Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ClinOmicsAI
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07298291
- Sponsor's protocol ID
- COAI-OPTICA-001
- Acronym
- OPTICA
- Status last verified
- Apr 2026
- First submitted
- 1 Dec 2025
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Exploratory study only
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07298291
- Acronym / sponsor ID
- OPTICA / COAI-OPTICA-001
- Conditions
- Age-Related (Dry) Macular Degeneration
- Keywords
- geographic atrophy, AMD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- ClinOmicsAIResearch network
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 23 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GA patients | Experimental | Procedure: AC Tap (anterior chamber paracenthesis)Anterior chamber paracentesis (ACP) |
Who may qualify
- Ages
- 50 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AC Tap (anterior chamber paracenthesis)anterior chamber paracenthesis (microvolume of eye fluid is taken) | Procedure or surgery | GA patients |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment to end of Visit 2
Incidence of Treatment-Emergent Adverse Events
1 secondary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No. Exploratory study only
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AC Tap (anterior chamber paracenthesis) in people with Age-Related (Dry) Macular Degeneration, run by ClinOmicsAI at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: From enrollment to end of Visit 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.