AMDX-2011P for Glaucoma

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Amydis Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 Glaucoma (POAG).

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.

What data supports the idea that AMDX-2011P for Glaucoma is an effective treatment?

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 XEN45 implant and Aurolab aqueous drainage implant. Without direct data on AMDX-2011P, we cannot conclude its effectiveness for Glaucoma based on the provided information. ^{1 2 3 4 5}

What safety data is available for AMDX-2011P in treating glaucoma?

The safety data for AMDX-2011P, also known as omidenepag isopropyl, includes several studies. A 3-month study in Japanese patients with open-angle glaucoma evaluated its adverse reactions. A Phase 3 study assessed its safety in patients with primary open-angle glaucoma or ocular hypertension who did not respond well to latanoprost. Phase 2 studies demonstrated its tolerability in patients with primary open-angle glaucoma and ocular hypertension, identifying 0.002% as the optimal dose. The RENGE study assessed its long-term safety over 12 months in patients with open-angle glaucoma or ocular hypertension. ^{6 7 8 9 10}

Is AMDX-2011P a promising treatment for Glaucoma?

The information provided does not mention AMDX-2011P or its effectiveness for treating glaucoma, so we can't say if it's promising based on this data. ^{11 12 13 14 15}

Eligibility Criteria

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

Treatment Details

Interventions

• AMDX-2011P (Other)

Participant Groups

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Global Research Management Glendale, CA

Eye Research Foundation Newport Beach, CA

Associated Retina Consultants Phoenix, AZ

Who Is Running the Clinical Trial?

Amydis Inc. Lead Sponsor

References

1. India 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. [2022] To study the efficacy of the Aurolab aqueous drainage implant (AADI) compared to Ahmed glaucoma valve (AGV) in patients with refractory glaucoma.

2. Netherlands pubmed.ncbi.nlm.nih.gov

Results of fluorouracil-augmented Xen45 implantation in primary open-angle and pseudoexfoliation glaucoma. [2021] To report the effectiveness and safety of 5-fluorouracil (5-FU)-augmented Xen45 implantation in primary open-angle glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).

3. India pubmed.ncbi.nlm.nih.gov

Efficacy of the XEN45 Implant in Advanced to End-stage Glaucoma Patients. [2022] To report the efficacy of the XEN45 implant in advanced to end-stage glaucoma patients, after a 6 months follow-up.

4. United States pubmed.ncbi.nlm.nih.gov

Clinical presentation and initial treatment patterns in patients with exfoliation glaucoma versus primary open-angle glaucoma. [2007] The presentation and initial response to treatment of consecutive patients with exfoliation glaucoma (PXE) and primary open-angle glaucoma (POAG) were evaluated prospectively.

5. New Zealand pubmed.ncbi.nlm.nih.gov

Long-Term Effectiveness of XEN 45 Gel-Stent in Open-Angle Glaucoma Patients. [2023] To assess the effectiveness of XEN45, either alone or in combination with phacoemulsification, in open-angle glaucoma (OAG) patients in clinical practice.

6. Japan 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. [2022] To assess the long-term safety and efficacy of omidenepag isopropyl (OMDI) 0.002% (a first-in-class, selective, non-prostaglandin, prostanoid EP2 receptor agonist), alone or administered concomitantly with timolol 0.5%, in patients with open-angle glaucoma (OAG, including normal-tension and exfoliation glaucoma) or ocular hypertension (OHT).

7. England pubmed.ncbi.nlm.nih.gov

Ocular hypotensive efficacy, safety and systemic absorption of AR-12286 ophthalmic solution in normal volunteers. [2013] To evaluate the ocular hypotensive efficacy, ocular and systemic safety, and systemic exposure of two formulations of 0.5% AR-12286 Ophthalmic Solution.

8. Japan pubmed.ncbi.nlm.nih.gov

Newly or switching effect of a selective EP2 agonist on intraocular pressure in Japanese patients with open-angle glaucoma. [2022] To evaluate omidenepag isopropyl (OMDI) for its efficacy in intraocular pressure control (IOP) and adverse reactions following administrations in Japanese patients with open-angle glaucoma (OAG) over a 3-month period.

9. United States 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. [2023] This study demonstrates the efficacy and safety of once-daily 0.002% omidenepag isopropyl (OMDI) in patients with primary open-angle glaucoma (POAG) or ocular hypertension (OHT) who do not respond or respond poorly to latanoprost.

10. United States 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. [2020] PRéCIS:: Three randomized, multicenter studies demonstrated the stable intraocular pressure-lowering effects and tolerability of omidenepag isopropyl in patients with primary open-angle glaucoma and ocular hypertension; 0.002% was identified as the optimal dose for further investigation.

11. New Zealand pubmed.ncbi.nlm.nih.gov

Surgical Outcomes of Glaucoma Drainage Device Implantation in Refractory Glaucoma Patients in Thailand. [2022] To study the surgical outcomes of glaucoma drainage device (GDD) implantation in refractory glaucoma patients.

12. Switzerland pubmed.ncbi.nlm.nih.gov

Outcomes of Glaucoma Drainage Device Surgery in Eyes with Treated Uveal Melanoma. [2022] We report patient safety and intraocular pressure (IOP) control after placement of a glaucoma drainage device (GDD) in eyes with a history of treated malignant uveal melanoma.

13. Netherlands pubmed.ncbi.nlm.nih.gov

Outcomes of Ahmed glaucoma valve FP8 versus FP7 in adult secondary glaucoma. [2021] To compare the outcomes of Ahmed glaucoma valve (AGV) pediatric FP8 versus the large-sized adult FP7 implants in an adult secondary glaucoma.

14. United States pubmed.ncbi.nlm.nih.gov

Internal glaucoma drainage device tube fenestration for uncontrolled postoperative intraocular pressure. [2018] To describe a novel approach to early postoperative intraocular pressure (IOP) control after glaucoma drainage device (GDD) implantation.

15. England pubmed.ncbi.nlm.nih.gov

The influence of etiology on surgical outcomes in neovascular glaucoma. [2022] The authors sought to evaluate visual outcomes in patients with varying etiologies of neovascular glaucoma (NVG), who were treated with glaucoma drainage devices (GDD).