AGN-193408 SR for Glaucoma

Recruiting at 61 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AbbVie

Must not be taking: Corticosteroids

Disqualifiers: Ocular trauma, Herpetic ocular diseases, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

96 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, AGN-193408 SR (a sustained-release implant), for individuals with open-angle glaucoma or ocular hypertension, conditions that can increase eye pressure and potentially lead to vision problems. The researchers aim to determine the safety and effectiveness of this treatment by testing different doses. Participants will receive either the new treatment or a standard eye drop in one eye, and a placebo (an inactive substance) in the other. Ideal candidates for this trial are those diagnosed with open-angle glaucoma or ocular hypertension in both eyes who can safely pause their current eye pressure treatments. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group, offering participants the opportunity to be among the first to benefit from this innovative approach.

Do I need to stop my current medications for the trial?

Participants must stop their current intraocular pressure (IOP) treatments as required by the study, but the protocol does not specify other medications. It's best to discuss your specific medications with the study team.

Is there any evidence suggesting that AGN-193408 SR is likely to be safe for humans?

Research has shown that AGN-193408 SR is generally well-tolerated by individuals with open-angle glaucoma or high eye pressure. Early study results suggest mild and manageable side effects. No serious side effects have been reported, indicating a positive safety profile.

Although specific side effects have not been detailed, the continuation of early to mid-stage trials suggests that side effects are not severe enough to halt the research. The ongoing trials focus on closely monitoring the safety and effectiveness of AGN-193408 SR to identify and manage any potential risks. ^{1 2 3 4 5}

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

Researchers are excited about AGN-193408 SR for glaucoma because it offers a novel delivery method compared to current treatments. Unlike the standard eye drops that need frequent application, AGN-193408 SR is designed for single-dose administration, potentially reducing the treatment burden for patients. This sustained-release formulation might maintain consistent therapeutic levels in the eye, which could lead to better management of intraocular pressure over time. Additionally, it could improve patient compliance and overall treatment outcomes.

What evidence suggests that AGN-193408 SR could be an effective treatment for glaucoma?

Research has shown that AGN-193408 SR may help lower eye pressure in people with open-angle glaucoma or high eye pressure. Lowering this pressure is important because it can prevent damage to the optic nerve, crucial for managing these conditions. The treatment works by affecting a substance involved in eye fluid control. Early findings suggest that AGN-193408 SR significantly reduces eye pressure, with previous studies showing promising results. This trial will evaluate different doses of AGN-193408 SR to determine its effectiveness in better controlling glaucoma symptoms and reducing the risk of vision loss for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for people with open-angle glaucoma or ocular hypertension in both eyes. Participants must be willing to stop their current eye pressure treatments for the study without risk, as judged by the investigator. They can't join if they've had certain eye procedures recently, use other eye meds, have allergies to study materials, are in another drug/device study, or have a history of specific eye conditions.

Inclusion Criteria

I have been diagnosed with glaucoma or high eye pressure in both eyes.

I have been diagnosed with glaucoma or high eye pressure in both eyes.

Participant is willing to withhold his/her IOP (Intraocular Pressure) treatments according to the study requirements, and in the opinion of the investigator, can do so without significant risk.

Exclusion Criteria

I have had corneal graft surgery or specific eye surgeries other than for astigmatism.

I have had a specific eye surgery in the lower part of my iris.

I am not allergic to any study drugs, their components, or related materials.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of AGN-193408 SR and daily vehicle eye drops or Lumigan in the study eye

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

36 months

Regular visits as per study protocol

What Are the Treatments Tested in This Trial?

Interventions

• AGN-193408 SR

Trial Overview The trial is testing AGN-193408 SR's safety and effectiveness compared to sham administration (placebo), Lumigan Vehicle (inactive form), and Lumigan (active treatment). It starts with dose escalation then moves into randomized groups where participants don't know which treatment they're getting.

How Is the Trial Designed?

Group I: Cohort 3 - Dose B Experimental Treatment 4 Interventions

AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group II: Cohort 3 - Dose A Experimental Treatment 4 Interventions

AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group III: Cohort 2 - Dose B Experimental Treatment 4 Interventions

AGN-193408 SR Dose B (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group IV: Cohort 2 - Dose A Experimental Treatment 4 Interventions

AGN-193408 SR Dose A (single dose on Day 1) + vehicle eye drops (once daily in the evening starting on Day 1) administered in the study eye. Lumigan (once daily in the evening starting on Day 1) + Sham AGN-193408 SR (single administration on Day 1) administered in the non-study eye.

Group V: Cohort 1 -Dose A Experimental Treatment 2 Interventions

Single dose of AGN-193408 SR Dose A administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.

Group VI: Cohort 1 - Dose B Experimental Treatment 2 Interventions

Single dose of AGN-193408 SR Dose B administered in the study eye on Day 1. One drop of Lumigan 0.01% administered in the non-study eye once daily every evening starting on Day 1.

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Allergan

Lead Sponsor

Trials

782

Recruited

277,000+

Brent Saunders

Allergan

Chief Executive Officer since 2015

JD and MBA from Temple University

Dr. David Nicholson

Allergan

Chief Medical Officer since 2015

MD from Harvard Medical School

Published Research Related to This Trial

Ahmed glaucoma valve (AGV) implantation was effective in treating refractory glaucoma in Asian patients, with a success rate of 74.5% and significant reductions in intraocular pressure post-surgery.

The procedure had a low complication rate, with hyphaemia being the most common issue (12.77%), and no serious complications leading to loss of vision, making AGV a safe option for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate outcomes of Ahmed glaucoma valve surgery in Asian patients with intractable glaucoma. Tai, MC., Cheng, JH., Chen, JT., et al.[2022]

The Baerveldt 250-mm2 Glaucoma Implant significantly reduced intraocular pressure (IOP) from a mean of 36.3 mmHg preoperatively to 15.8 mmHg postoperatively over an average follow-up of 22.8 months, indicating its efficacy in managing glaucoma.

Success rates for the implant were high, with 79% of patients maintaining target IOP levels without further surgery or severe complications at 24 months, demonstrating its reliability as a treatment option for adult refractory glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical experience with the Baerveldt 250-mm2 Glaucoma Implant. WuDunn, D., Phan, AD., Cantor, LB., et al.[2006]

The XEN gel stent implantation significantly reduced intraocular pressure (IOP) in patients with open-angle glaucoma who had previously undergone filtering surgeries, achieving a 49.5% reduction in IOP over 18 months.

The procedure demonstrated high safety, with no intraoperative or postoperative complications reported, and 70% of eyes maintained controlled IOP without the need for anti-glaucomatous medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

XEN Gel Stent Implantation in Eyes With Previous Glaucoma Filtering Surgeries: A Case Series. Vieira, R., Leite, J., Figueiredo, A., et al.[2023]

Baerveldt glaucoma implants significantly reduced intraocular pressure (IOP) from an average of 36.5 mmHg preoperatively to 15.3 mmHg postoperatively in a study of 124 Asian patients over an average follow-up of 33.4 months.

The implants demonstrated a satisfactory success rate, with 54% of eyes achieving complete success, while complications occurred in 34.7% of cases, indicating that while effective, some patients may require further surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermediate-term outcome of Baerveldt glaucoma implants in Asian eyes. Seah, SK., Gazzard, G., Aung, T.[2022]

The 350-mm2 Baerveldt glaucoma implant demonstrated a higher overall success rate of 87% in controlling intraocular pressure (IOP) compared to 70% for the 500-mm2 implant over an average follow-up of 37 months.

Both implants showed similar rates of visual acuity improvement and complications, indicating that while the 350-mm2 implant is more effective for IOP control, both options are comparably safe.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of the 350-mm2 versus the 500-mm2 Baerveldt implant: longer term results: is bigger better? Britt, MT., LaBree, LD., Lloyd, MA., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04499248

AGN-193408 SR in the Treatment of Open-angle ... A Phase 1/2 Study to Evaluate the Safety and Efficacy of AGN-193408 SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

2. withpower.com withpower.com/trial/phase-3-glaucoma-open-angle-10-2020-0d524

AGN-193408 SR for Glaucoma The Baerveldt 250-mm2 Glaucoma Implant significantly reduced intraocular pressure (IOP) from a mean of 36.3 mmHg preoperatively to 15.8 mmHg postoperatively ...

3. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=1833-201-407

AGN-193408 SR in the Treatment of Open-angle ... ... (Cohort 2) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension.

4. prnewswire.com prnewswire.com/news-releases/open-angle-glaucoma-market-outlook-brightens-as-emerging-therapies-reshape-treatment-paradigms--delveinsight-302550749.html

Open-Angle Glaucoma Market Outlook Brightens as ... Some of the key open-angle glaucoma therapies in clinical trials include Citicolinem, PA5108, AGN-193408 SR, PER-001, AMDX-2011P, and others.

5. pharmaceutical-technology.com pharmaceutical-technology.com/data-insights/agn-193408-sr-abbvie-open-angle-glaucoma-likelihood-of-approval/

AGN-193408 SR by AbbVie for Open-Angle Glaucoma AGN-193408 SR is under development for the treatment of open-angle glaucoma and ocular hypertension. The drug candidate acts by targeting prostaglandin F2 ...

6. adisinsight.springer.com adisinsight.springer.com/drugs/800059885

AGN 193408 sustained-release - AbbVie - AdisInsight - Springer AGN 193408 is a sustained-release intracameral implant, targeting PGF2 alpha receptor, is being developed by AbbVie (previously known as Allergan) for the.

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04499248/agn-193408-sr-in-the-treatment-of-open-angle-glaucoma-or-ocular-hypertension

AGN-193408 SR in the Treatment of Open-angle ... ... ) and (Cohort 3) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension.