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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension

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

AGN-193408 SR in the Treatment of Open-angle Glaucoma or Ocular Hypertension (NCT04499248) is a Phase 1 / Phase 2 interventional studying Open-angle Glaucoma and Ocular Hypertension, sponsored by AbbVie. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (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

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Open-angle Glaucoma, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 96 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Open-angle Glaucoma subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. - Diagnosis of either OAG \[open-angle glaucoma\] (ie, \[POAG\], pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes. - Must be pseudophakic (at least 4 months postcataract surgery prior to treatment administration \[Cycle 1 Day 1 Administration visit\]) (Cohort 3 only). Who Should NOT Join This Trial: - Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine). - Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit. - History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515 Travoprost XR). - History of laser trabeculoplasty within 6 months prior to screening in the study eye. - History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye. - History or evidence of complicated cataract/lens surgery, as stated in the protocol. - Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration. - Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty \[DSEK\], Descemet's Membrane Endothelial Keratoplasty \[DMEK\]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye. - History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus). ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * 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. * Diagnosis of either OAG \[open-angle glaucoma\] (ie, \[POAG\], pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes. * Must be pseudophakic (at least 4 months postcataract surgery prior to treatment administration \[Cycle 1 Day 1 Administration visit\]) (Cohort 3 only). Exclusion Criteria: * Known allergy or sensitivity to any study medication or its components, any component of the delivery vehicle, procedure-related materials, or diagnostic agents used during the study (eg, topical anesthetic, dilating drops, fluorescein, povidone-iodine). * Concurrent or anticipated enrollment in an investigational drug or device study or participation in such a study within 2 months prior to the Baseline visit through the final study visit. * History of intracameral implant in the study eye (eg, Bimatoprost SR, OTX-TIC, ENV515 Travoprost XR). * History of laser trabeculoplasty within 6 months prior to screening in the study eye. * History or evidence of clinically relevant, substantial ocular trauma (eg, a traumatic cataract, traumatic angle recession, etc.) in the study eye. * History or evidence of complicated cataract/lens surgery, as stated in the protocol. * Intraocular surgery (including cataract surgery) in the study eye within the 4 months prior to treatment administration. * Any history of corneal graft, including partial grafts (eg, Descemet's Stripping Endothelial Keratoplasty \[DSEK\], Descemet's Membrane Endothelial Keratoplasty \[DMEK\]); or incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions in the study eye. * History of herpetic ocular diseases in either eye (including herpes simplex virus and varicella zoster virus). * Anticipated need for any incisional or laser ocular surgery in either eye during the study. * History of anatomically narrow angle resulting in evidence of angle changes or any history or closed angle glaucoma in the study eye. * History or evidence of a peripheral iridotomy/iridectomy in the inferior iris in the study eye. * Any history of trabeculectomy or other types of incisional glaucoma surgery, including a glaucoma seton or aqueous bypass stents in either eye, or minimally invasive glaucoma surgery (MIGS) type trabecular meshwork surgeries in the study eye. * Anticipated use of corticosteroids in either eye except for permitted interventions or systemically during the study, or historical use prior to Baseline within: * 3 years: intraocular fluocinolone acetonide * 6 months: intraocular corticosteroid(s) other than fluocinolone; any injectable periocular or sub-Tenon's/subconjunctival corticosteroid * 2 months: systemic (eg, oral, intramuscular, intravenous) or topical ocular corticosteroids * 2 weeks: dermal corticosteroids applied to skin of the eyelid(s), around the eye, or adnexa. * Anticipated use of other topical ocular medications in either eye except for permitted interventions. * The anticipated wearing of contact lenses in the study eye (Cohort 1) and both eyes (Cohorts 2 and 3) during the study that deviates from the following (contact lens wear is allowed during the study, but is to be temporarily discontinued before study visits, and before and after an Administration Day according to the following): * Use of soft lenses should be discontinued at least 3 days prior to Baseline, and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to Baseline * Use of soft lenses should be discontinued at least 3 days and use of rigid gas permeable or hard contact lenses should be discontinued at least 1 week prior to a scheduled study visit or Administration Day visit * Use of contact lenses of any kind should be discontinued for 1 week following any AGN-193408 SR administration * Central corneal thickness of \< 480 or \> 620 micrometers in both eyes. * Visual field loss in the study eye that, in the opinion of the investigator, is functionally significant (eg, split fixation, field defect within the central 10 degrees that is visually significant or likely to cause central visual impairment upon progression) or shows evidence of progressive visual field loss within the year prior to Baseline. * Evidence of macular edema in either eye during screening or in participant's medical history. * At Screening, evidence of posterior synechia behind the iris inferiorly in the study eye that in the investigator's opinion may inhibit the ability to safely receive at least 1 AGN-193408 SR implant (Cohort 3 only).

Treatments Being Tested

DRUG

AGN-193408 SR

An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant into the anterior chamber of the study eye.

OTHER

Lumigan

Control Treatment in Fellow Eye Lumigan 0.01% is a topical eye drop that is a solution containing 0.1 mg/mL bimatoprost

OTHER

Sham Administration

Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.

OTHER

Lumigan Vehicle

Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 2.

DRUG

AGN-193408 SR

An implant containing preservative-free AGN-193408 dispersed in a biodegradable polymer matrix. Implants are preloaded into an applicator to facilitate insertion of the implant in the study eye.

OTHER

Sham Administration

Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.

OTHER

Lumigan Vehicle

Vehicle eye drops (for masking) will be administered once daily in the evening starting on Day 1 in the study eye during Cohort 3.

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Horizon Eye Specialists & Lasik Center - Sun City /ID# 252153
Sun City, Arizona, United States
Global Research Management /ID# 241699
Glendale, California, United States
United Medical Research Institute /ID# 241701
Inglewood, California, United States
Lakeside Vision Center /ID# 241698
Irvine, California, United States
The Eye Research Foundation /ID# 234528
Newport Beach, California, United States
Sacramento Eye Consultants /ID# 241697
Sacramento, California, United States
Premiere Practice Management LLC /ID# 235957
Torrance, California, United States
Wolstan & Goldberg Eye Associates /ID# 241700
Torrance, California, United States
Connecticut Eye Consultants P.C. /ID# 235862
Danbury, Connecticut, United States
Brandon Eye Associates - Brandon /ID# 276600
Brandon, Florida, United States
Nature Coast Clinical Research - Crystal River /ID# 237781
Crystal River, Florida, United States
Advanced Research, LLC /ID# 276987
Deerfield Beach, Florida, United States
University of Florida Health Ophthalmology - Jacksonville /ID# 243122
Jacksonville, Florida, United States
East Florida Eye Institute /ID# 235762
Stuart, Florida, United States
Logan Ophthalmic Research Inc. /ID# 252087
Tamarac, Florida, United States
Coastal Research Associates /ID# 234649
Roswell, Georgia, United States
Thomas Eye Group PC /ID# 266775
Sandy Springs, Georgia, United States
University of Illinois Hospital and Health Sciences System /ID# 253630
Chicago, Illinois, United States
Midwest Medical Advisors Inc /ID# 235845
Carmel, Indiana, United States
Indiana University - Glick Eye Institute /ID# 235887
Indianapolis, Indiana, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT04499248), the sponsor (AbbVie), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT04499248 clinical trial studying?

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-groups (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 The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT04499248?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT04499248?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT04499248. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT04499248. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.