AMDX-2011P for Glaucoma

Recruiting at 2 trial locations

Overseen By David Bingaman

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amydis Inc.

Disqualifiers: Illiteracy, Ocular pathology, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests AMDX-2011P to determine its ability to detect amyloid deposits in the eyes of individuals with Primary Open Angle Glaucoma (POAG). Researchers will use two different doses of AMDX-2011P, administered by injection, to assess its effectiveness. Individuals diagnosed with POAG in both eyes who can focus their vision may qualify for this study. As a Phase 2 trial, the research aims to measure the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that AMDX-2011P has undergone testing in several studies to assess its safety. In a 3-month study involving Japanese patients with open-angle glaucoma, the treatment was well-tolerated, with most participants experiencing no serious side effects.

Other studies have examined AMDX-2011P in conditions such as Alzheimer's and cerebral amyloid angiopathy (CAA). These studies also assessed its safety and found that most participants experienced no major issues after a single dose.

Overall, available evidence suggests that AMDX-2011P is generally safe, with few serious side effects reported. However, this information comes from various studies, and results can vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for glaucoma?

Unlike the standard treatments for glaucoma, which often include eye drops, laser therapy, or surgery, AMDX-2011P is administered as a single bolus intravenous injection, offering a unique delivery method. This method could potentially improve patient compliance and provide more consistent dosing. Additionally, AMDX-2011P may work by targeting specific pathways in the eye associated with fluid drainage, offering a novel mechanism of action compared to existing therapies. Researchers are excited about the potential for AMDX-2011P to offer a more efficient and possibly faster-acting alternative to current glaucoma treatments.

What evidence suggests that AMDX-2011P is effective for identifying amyloid deposits in the retina of patients with Primary Open Angle Glaucoma?

Research has shown that AMDX-2011P is designed to detect amyloid deposits in the retina, which are linked to Primary Open Angle Glaucoma (POAG). These amyloid deposits are proteins that can accumulate and potentially affect vision. Early studies suggest that AMDX-2011P acts as a marker to identify these deposits in the eye. Although specific data on AMDX-2011P's effectiveness in treating glaucoma is not yet available, its ability to highlight these proteins could enhance understanding and management of the condition. This may lead to improved diagnosis and monitoring of glaucoma progression. Participants in this trial will receive either a 50 mg or 100 mg dose of AMDX-2011P for diagnostic review. ^{1 2 4 6 7}

Who Is on the Research Team?

David Bingaman

Principal Investigator

Amydis Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with open angle glaucoma in both eyes.

I can focus my eyesight on a specific point.

I have glaucoma damage in both eyes confirmed by an eye exam.

Exclusion Criteria

I have glaucoma or cataracts but no other eye conditions.

Ocular media is not sufficiently clear to obtain acceptable quality images

Participants unable to read or write

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a single IV bolus injection of AMDX-2011P followed by safety assessments, retinal imaging, and blood collection for PK analysis

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and retinal imaging

8 days

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• AMDX-2011P

How Is the Trial Designed?

Group I: AMDX-2011P 50 mg Experimental Treatment 1 Intervention

AMDX2011P mg 50 (2ml) single bolus injection intravenous for diagnostic review

Group II: AMDX-2011P 100 mg Experimental Treatment 1 Intervention

AMDX2011P 100mg (4ml) single bolus injection intravenous for diagnostic review

Who Is Running the Clinical Trial?

Amydis Inc.

Lead Sponsor

Trials

4

Recruited

140+

Published Research Related to This Trial

A new technique called internal GDD tube fenestration was successfully used in two patients to significantly lower elevated intraocular pressure (IOP) after glaucoma drainage device implantation, reducing IOP by over 50%.

This method, which involves using a 30-gauge needle to perforate the GDD tube, was performed without any complications, offering a promising option for early IOP control post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internal glaucoma drainage device tube fenestration for uncontrolled postoperative intraocular pressure. Campbell, RJ., Buys, YM., McIlraith, IP., et al.[2018]

The Aurolab aqueous drainage implant (AADI) demonstrated a higher complete success rate (68.42%) compared to the Ahmed glaucoma valve (AGV) (26.31%) at 6 months, indicating better long-term efficacy in managing refractory glaucoma.

While the AGV initially resulted in lower intraocular pressure (IOP) at 1 week post-surgery, by 6 months, the IOP levels were comparable between both groups, suggesting that AADI may provide sustained control of IOP with fewer required medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective randomized controlled study of Aurolab aqueous drainage implant versus Ahmed glaucoma valve in refractory glaucoma: A pilot study. Rathi, SG., Seth, NG., Kaur, S., et al.[2022]

Patients with exfoliation glaucoma (PXE) presented with significantly worse visual field defects and higher intraocular pressure (IOP) compared to those with primary open-angle glaucoma (POAG), indicating a more severe initial condition for PXE patients.

PXE patients required more treatment steps and were more likely to need surgical interventions to control IOP, highlighting the challenges in managing this type of glaucoma compared to POAG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical presentation and initial treatment patterns in patients with exfoliation glaucoma versus primary open-angle glaucoma. Konstas, AG., Stewart, WC., Stroman, GA., et al.[2007]

In a study of 120 eyes treated with glaucoma drainage devices (GDD) for neovascular glaucoma (NVG), patients with proliferative diabetic retinopathy (PDR) had better visual outcomes compared to those with retinal vein occlusions (RVO), highlighting the impact of underlying conditions on treatment efficacy.

The study found that both Ahmed and Baerveldt GDD devices provided similar control of intraocular pressure (IOP) and visual acuity, but Ahmed devices required more glaucoma medications on average, suggesting differences in management needs between the two types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The influence of etiology on surgical outcomes in neovascular glaucoma. Medert, CM., Sun, CQ., Vanner, E., et al.[2022]

In a study involving 18 normal adult volunteers, both formulations of 0.5% AR-12286 Ophthalmic Solution significantly reduced intraocular pressure (IOP) by 3 to 7 mm Hg, demonstrating its efficacy as a treatment for ocular hypertension.

The formulations showed low systemic absorption, with most participants having no measurable drug levels in their blood, and the ocular side effects reported were mild and short-lived, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular hypotensive efficacy, safety and systemic absorption of AR-12286 ophthalmic solution in normal volunteers. Kopczynski, C., Novack, GD., Swearingen, D., et al.[2013]

In a study of 29 eyes with primary open-angle glaucoma and pseudoexfoliation glaucoma, 5-fluorouracil (5-FU)-augmented Xen45 implantation significantly reduced intraocular pressure (IOP) by an average of 31.7% at the final visit, demonstrating its effectiveness in managing glaucoma.

The procedure also led to a substantial decrease in the number of glaucoma medications needed, from an average of 2.83 preoperatively to 0.86 at the final follow-up, indicating improved patient management with this treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of fluorouracil-augmented Xen45 implantation in primary open-angle and pseudoexfoliation glaucoma. Başer, EF., Seymenoğlu, RG.[2021]

Both the pediatric FP8 and adult FP7 Ahmed glaucoma valve implants effectively reduced intraocular pressure (IOP) in adults with secondary glaucoma, achieving similar final IOP levels and success rates of 75% after 20 months.

While both implants had comparable overall outcomes, the FP8 group experienced more conjunctiva-related complications, particularly in patients with prior surgeries and preoperative scarring, indicating the need for careful patient selection when using smaller implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Ahmed glaucoma valve FP8 versus FP7 in adult secondary glaucoma. Ramyashri, S., Raj, N., Pradhan, A., et al.[2021]

The XEN45 implant significantly reduced intraocular pressure (IOP) in open-angle glaucoma patients, lowering it from an average of 19.1 mmHg to 14.9 mmHg over 36 months, regardless of whether it was used alone or with cataract surgery.

Both treatment groups (XEN-solo and XEN+Phacoemulsification) showed a significant decrease in the number of antiglaucoma medications needed, from an average of 2.1 to 0.2, indicating effective management of glaucoma with a good safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients. Marcos-Parra, MT., Salinas-López, JA., Mateos-Marcos, C., et al.[2023]

Omidenepag isopropyl (OMDI) 0.002% significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension over 52 weeks, with reductions of up to 8.4 mmHg when used with timolol.

The treatment was generally safe, with most adverse events being mild; however, higher rates of conjunctival hyperemia were observed when OMDI was used alongside timolol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Twelve-month efficacy and safety of omidenepag isopropyl, a selective EP2 agonist, in open-angle glaucoma and ocular hypertension: the RENGE study. Aihara, M., Lu, F., Kawata, H., et al.[2022]

Omidenepag isopropyl (OMDI) significantly reduced intraocular pressure (IOP) in untreated open-angle glaucoma patients, dropping from a baseline of 15.7 mmHg to 13.7 mmHg after 3 months, indicating its efficacy as a first-line treatment.

Switching from prostaglandin F receptor agonists to OMDI in patients already on treatment did not result in significant changes in IOP, suggesting that while OMDI is effective as a new treatment, it may not provide additional benefits when replacing existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly or switching effect of a selective EP2 agonist on intraocular pressure in Japanese patients with open-angle glaucoma. Ueda, K., Sakata, R., Fujishiro, T., et al.[2022]

In a study of 144 eyes from glaucoma patients undergoing drainage device implantation, the five-year success rate for refractory primary glaucoma was significantly higher at 65.8% compared to 45.2% for secondary glaucoma, indicating that primary glaucoma patients may benefit more from this surgical intervention.

Lens-induced glaucoma was identified as a strong predictor of failure in glaucoma drainage device implantation, highlighting the need for careful consideration of patient type when planning surgical treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical Outcomes of Glaucoma Drainage Device Implantation in Refractory Glaucoma Patients in Thailand. Rojananuangnit, K., Jiaranaisilawong, P., Rattanaphaithun, O., et al.[2022]

In a study of 16 eyes with a history of treated uveal melanoma, the placement of a glaucoma drainage device (GDD) effectively reduced intraocular pressure (IOP) from an average of 30.5 mm Hg to 15.9 mm Hg after one year, achieving an 80% success rate.

There were no cases of local treatment failure or increased risk of local or systemic recurrence of melanoma, suggesting that GDD placement is safe for patients with a history of uveal melanoma, although further research with larger samples is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of Glaucoma Drainage Device Surgery in Eyes with Treated Uveal Melanoma. Fatehi, N., McCannel, TA., Giaconi, J., et al.[2022]

The XEN45 implant significantly reduced intraocular pressure (IOP) in advanced to end-stage glaucoma patients, with mean IOP dropping from 19.67 mm Hg to 13.18 mm Hg after 6 months, and the number of antihypertensive medications decreased from a median of 4 to 0.

The procedure demonstrated a high success rate, with 61.5% of eyes achieving complete success, although some patients experienced complications such as choroidal detachment (20.51%) and hypotony (17.95%), which resolved within two weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the XEN45 Implant in Advanced to End-stage Glaucoma Patients. Hindi, I., Berkowitz, E., Waizer, I., et al.[2022]

The study found that once-daily 0.002% omidenepag isopropyl (OMDI) significantly reduced intraocular pressure (IOP) by an average of 2.96 mm Hg in patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) who did not respond well to latanoprost, indicating its efficacy as a treatment option.

Safety assessments showed no significant adverse events during the OMDI treatment, suggesting that it is a safe alternative for patients with POAG or OHT who are low or non-responders to existing therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omidenepag Isopropyl in Latanoprost Low/Non-Responders with Primary Open-Angle Glaucoma or Ocular Hypertension: A Phase 3, Non-Randomized, Two-Phase, Open-Label Study. Panarelli, JF., Bowden, EC., Tepedino, ME., et al.[2023]

Omidenepag isopropyl, particularly at a concentration of 0.002%, effectively lowers intraocular pressure (IOP) in patients with primary open-angle glaucoma and ocular hypertension, showing results comparable to latanoprost and significantly better than placebo.

The treatment was well tolerated, with most side effects being mild, and the optimal dose for further investigation was determined to be 0.002%, as it had a lower incidence of adverse events compared to the 0.0025% concentration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase 2, Randomized, Dose-finding Studies of Omidenepag Isopropyl, a Selective EP2 Agonist, in Patients With Primary Open-angle Glaucoma or Ocular Hypertension. Aihara, M., Lu, F., Kawata, H., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06223048?draw=2&rank=1

A Study of AMDX-2011P in Participants With Primary Open ... The purpose of this research study is to assess the ability of AMDX- 2011P to identify amyloid deposits in the retina of participants with Primary Open Angle ...

2. withpower.com withpower.com/trial/phase-2-glaucoma-open-angle-11-2023-92924

AMDX-2011P for Glaucoma The available research does not provide any specific data on the effectiveness of AMDX-2011P for Glaucoma. Instead, it focuses on other treatments like the ...

3. biospace.com biospace.com/amydis-launches-phase-2-glaucoma-clinical-program-using-novel-retinal-tracer-to-detect-amyloid-beta

Amydis Launches Phase 2 Glaucoma Clinical Program ... Amydis has launched a Phase 2 open label, blinded endpoint assessment study of AMDX-2011P as a retinal tracer in subjects with primary open ...

4. digital.glaucomaphysician.net digital.glaucomaphysician.net/articles/research-and-industry-news-in-glaucoma?article_id=4722038&i=814939

Research and industry news in glaucoma A phase 2 study of Amydis Inc's novel retinal tracer AMDX-2011P for detecting amyloid beta in glaucoma ... • 6-year Data Demonstrate Effective, ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06514001

A Study of AMDX-2011P in Participants With Alzheimer's ... Diagnosis of glaucoma, or suspect of having glaucoma in either eye as determined by an ophthalmologist as a clinical investigator, based on results from the eye ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-amdx-2011p-in-participants-with-primary-open-angle-glaucoma

A Study of AMDX-2011P in Participants With Primary Open ... This open-label, masked endpoint assessment study will evaluate safety, tolerability, plasma pharmacokinetics (PK) and biological activity ...

7. trialx.com trialx.com/clinical-trials/listings/287865/a-study-of-amdx-2011p-in-participants-with-caa/

A Study of AMDX-2011P in Participants With CAA The purpose of this study is to assess safety, tolerability, plasma pharmacokinetics and biologic activity of a single intravenous dose of AMDX- ...