AC Tap for Age-Related Macular Degeneration

(OPTICA Trial)

Overseen By BRUNO GAGNON, BPharm MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ClinOmicsAI

Must not be taking: Anticoagulants

Disqualifiers: Ocular infection, Intraocular surgery, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to study proteins in the eye to assist individuals with geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that impairs vision. The researchers are testing the safety of a procedure called anterior chamber paracentesis (ACP), or AC Tap, which involves taking a tiny fluid sample from the eye. Suitable candidates for this trial have been diagnosed with GA due to AMD and have vision correctable to at least 20/200 in the study eye. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could lead to new insights and treatments for GA.

Will I have to stop taking my current medications?

The trial requires that you stop taking systemic anticoagulation therapy (blood thinners) if it cannot be safely discontinued before the procedure. For other medications, the protocol does not specify if you need to stop taking them.

What prior data suggests that this technique is safe for patients with geographic atrophy?

Research has shown that anterior chamber paracentesis (ACP), the procedure tested in this trial, is generally safe. Studies indicate it effectively relieves eye pressure before certain injections, preventing sudden increases in pressure. For years, ACP has lowered pressure and removed unwanted fluids or blood from the eye.

Evidence suggests that ACP is well-tolerated, with most people not experiencing serious side effects. Many patients have undergone the procedure, and no major safety concerns have been reported. Overall, the data supports ACP as a low-risk procedure for those considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AC Tap for age-related macular degeneration (AMD) because it's exploring a new approach called anterior chamber paracentesis (ACP). Unlike standard treatments for AMD, which often involve repeated injections into the eye to slow vision loss, ACP involves removing a small amount of fluid from the eye's anterior chamber. This technique could potentially reduce inflammation and pressure in the eye, offering a different way to manage the condition. By targeting the underlying eye environment, ACP might provide an innovative option for patients with geographic atrophy (GA) associated with AMD, potentially improving or stabilizing vision with fewer interventions.

What evidence suggests that this technique is effective for geographic atrophy?

Research has shown that anterior chamber paracentesis (ACP), or AC Tap, can benefit individuals with age-related macular degeneration (AMD). Past studies found that ACP reduces damage to the eye's nerve fibers when combined with anti-VEGF therapy, a common AMD treatment. It also prevents increases in eye pressure after injections, enhancing treatment safety. Additionally, ACP has been linked to better eye health outcomes for some AMD patients. This trial will evaluate ACP's effectiveness in managing AMD. ^{1 4 5 6 7}

Are You a Good Fit for This Trial?

This trial is for men and women aged 50-89 with geographic atrophy (GA) due to age-related macular degeneration, confirmed by specific eye imaging tests. Participants must have a certain level of vision in the study eye. People without retinal disease can join as controls. All participants need to consent to the study's procedures.

Inclusion Criteria

My eye condition is confirmed as GA due to AMD, with specific tests.

I don't have any eye diseases affecting my retina.

My vision in the study eye is at least 20/200 with correction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Procedure

Anterior chamber paracentesis (ACP) performed to collect Aqueous Humor (AH) for proteomic analysis

1 day

1 visit (in-person)

Follow-up Procedure

Second anterior chamber paracentesis (ACP) performed to collect AH for proteomic analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AC Tap

Trial Overview

The trial is testing the safety of a procedure called anterior chamber paracentesis (ACP), which involves removing fluid from the front part of the eye for proteomic analysis, in patients with GA secondary to AMD.

How Is the Trial Designed?

Group I: GA patients Experimental Treatment 1 Intervention

Anterior chamber paracentesis (ACP)

Who Is Running the Clinical Trial?

ClinOmicsAI

Lead Sponsor

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6402161/

Anterior chamber paracentesis during intravitreal injections in ...

Retinal nerve fiber loss in anti-VEGF therapy for age-related macular degeneration can be decreased by anterior chamber paracentesis.

2.

researchgate.net

researchgate.net/publication/331556969_Anterior_chamber_paracentesis_during_intravitreal_injections_in_observational_trials_Effectiveness_and_safety_and_effects

(PDF) Anterior chamber paracentesis during intravitreal ...

Abstract A paracentesis prior to an intravitreal injection is a very safe procedure and can prevent IOP-spikes after injections.

3.

journals.sagepub.com

journals.sagepub.com/doi/pdf/10.1177/11206721251389427?download=true

Multi-centre outcomes of patients receiving anti-VEGF ...

ACP; anterior chamber paracentesis, AMD; age-related macular degeneration ... and has also been associated with more favourable anatomical outcomes in some AMD.

4.

withpower.com

withpower.com/trial/phase-macular-degeneration-10-2025-fd522

AC Tap for Age-Related Macular Degeneration

The trial is testing the safety of a procedure called anterior chamber paracentesis (ACP), which involves removing fluid from the front part of the eye for ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41130930/

Multi-centre outcomes of patients receiving anti-VEGF ...

ResultsThe matched cohort had a mean age of 71.06 ± 11.44 years, with 61.4% female participants. ACP eyes had worse baseline VA, higher IOP, and ...

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666914524000538?dgcid=rss_sd_all

Using Electronic Health Record Data to Determine the ...

Paracentesis of the anterior chamber (AC) has been used for decades to therapeutically lower intraocular pressure and remove pathologic tissues such as blood or ...

7.

aao.org

aao.org/eyenet/article/iris-registry-low-usage-ac-tap

IRIS Registry Data Show Low Usage of AC Tap

The mean age of patients was 68.6 ± 13.6 years; 60.2% were female, and 74.9% were White. During the study period, the prevalence of viral ...