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

Ocular Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04499248
• Other study ID #: 1833-201-407
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 16, 2020
• Est. completion date: August 30, 2027

Study information

• Verified date: April 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]) in the study eye (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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-angle Glaucoma

Intervention

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
• Sham Administration
Needleless applicator contacting similar intracameral insertion location on eye as AGN-193408 SR.
• 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 behind the study eye.

Other:
• Sham Administration
Needleless applicator contacting similar insertion location on eye as AGN-193408 SR.
• 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

Country	Name	City	State
Japan	The University of Tokyo Hospital /ID# 238871	Bunkyo-ku	Tokyo
Japan	University of Yamanashi Hospital /ID# 238642	Chuo-shi	Yamanashi
Japan	Shimane University Hospital /ID# 238641	Izumo-shi	Shimane
Japan	Kitasato University Hospital /ID# 238880	Sagamihara-shi	Kanagawa
United States	Asheville Eye Associates /ID# 234963	Asheville	North Carolina
United States	Ophthalmic Consultants of Boston /ID# 236535	Boston	Massachusetts
United States	Midwest Medical Advisors Inc /ID# 235845	Carmel	Indiana
United States	Scott and Christie and Associates /ID# 252284	Cranberry Township	Pennsylvania
United States	Nature Coast Clinical Research - Crystal River /ID# 237781	Crystal River	Florida
United States	Connecticut Eye Consultants P.C. /ID# 235862	Danbury	Connecticut
United States	Drs Fine Hoffman & Sims LLC /ID# 235919	Eugene	Oregon
United States	Global Research Management /ID# 241699	Glendale	California
United States	Indiana University - Glick Eye Institute /ID# 235887	Indianapolis	Indiana
United States	United Medical Research Institute /ID# 241701	Inglewood	California
United States	Lakeside Vision Center /ID# 241698	Irvine	California
United States	University of Florida Health Ophthalmology - Jacksonville /ID# 243122	Jacksonville	Florida
United States	Piedmont Eye Center /ID# 246455	Lynchburg	Virginia
United States	Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365	Newark	New Jersey
United States	The Eye Research Foundation /ID# 234528	Newport Beach	California
United States	Oklahoma Eye Surgeons /ID# 252089	Oklahoma City	Oklahoma
United States	Vistar Eye Center /ID# 234811	Roanoke	Virginia
United States	Coastal Research Associates /ID# 234649	Roswell	Georgia
United States	Sacramento Eye Consultants /ID# 241697	Sacramento	California
United States	St. George Eye Center /ID# 236200	Saint George	Utah
United States	Tekwani Vision Center /ID# 235149	Saint Louis	Missouri
United States	Advancing Vision Research /ID# 236683	Smyrna	Tennessee
United States	Northern New Jersey Eye Institute PA /ID# 241545	South Orange	New Jersey
United States	East Florida Eye Institute /ID# 235762	Stuart	Florida
United States	Walman Eye Center /ID# 252153	Sun City	Arizona
United States	Logan Ophthalmic Research Inc. /ID# 252087	Tamarac	Florida
United States	Premiere Practice Management LLC /ID# 235957	Torrance	California
United States	Wolstan & Goldberg Eye Associates /ID# 241700	Torrance	California
United States	James D Branch MD /ID# 234560	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Hour 0 Intraocular Pressure (IOP) in the Study Eye	IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.	Baseline to Month 24
Primary	Number of participants experiencing treatment emergent adverse events		Baseline to Month 24
Secondary	Time to Rescue Treatment or Re-Treatment in the Study Eye	Time to rescue treatment or the second treatment is defined as the time between the first treatment and the second treatment in the study eye.	Baseline to Month 24

External Links

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