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

Sponsor

AbbVie (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04499248

Collaborator

(none)

Enrollment

Locations

Arms

53.3

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a multicenter, open-label, dose escalation (Cohort 1) to masked, randomized, parallel-group (Cohort 2) study to evaluate the safety and efficacy of AGN-193408 SR in participants with open-angle glaucoma or ocular hypertension

Condition or Disease	Intervention/Treatment	Phase
Open-angle Glaucoma Ocular Hypertension	Drug: AGN-193408 SR Other: Lumigan Other: Sham Administration Other: Lumigan Vehicle	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

84 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 16, 2020

Anticipated Primary Completion Date :

Apr 26, 2025

Anticipated Study Completion Date :

Apr 26, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort 1 -Dose A 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.	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 Names: Active Comparator
Experimental: Cohort 1 - Dose B 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.	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 Names: Active Comparator
Experimental: Cohort 2 - Dose A 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.	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 Names: Active Comparator 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. Other Names: Vehicle
Experimental: Cohort 2 -Dose B 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.	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 Names: Active Comparator 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. Other Names: Vehicle

Outcome Measures

Primary Outcome Measures

Change from Baseline in Time-Matched Intraocular Pressure (IOP) in the Study Eye [Baseline to Month 24]
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.
Number of participants experiencing treatment emergent adverse events [Baseline to Month 24]

Secondary Outcome Measures

Time to Rescue Treatment or Re-Treatment in the Study Eye [Baseline to Month 24]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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, primary OAG, pseudoexfoliation glaucoma,pigmentary glaucoma) or OHT (ocular hypertension) in both eyes.

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: eg, surgery resulting in complicated lens placement (such a anterior chamber intraocular lens implant [IOL], sulcus IOL, aphakia, etc.) or intraoperative complications (such as a posterior capsular tear [with or without vitreous loss], substantial iris trauma, etc.).
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 (Cohort 2) 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	United Medical Research Institute /ID# 241701	Inglewood	California	United States	90301
2	Lakeside Vision Center /ID# 241698	Irvine	California	United States	92604
3	The Eye Research Foundation /ID# 234528	Newport Beach	California	United States	92663-3637
4	Sacramento Eye Consultants /ID# 241697	Sacramento	California	United States	95815
5	Premiere Practice Management LLC /ID# 235957	Torrance	California	United States	90505
6	Wolstan & Goldberg Eye Associates /ID# 241700	Torrance	California	United States	90505
7	Connecticut Eye Consultants P.C. /ID# 235862	Danbury	Connecticut	United States	06810
8	Nature Coast Clinical Research - Crystal River /ID# 237781	Crystal River	Florida	United States	34429
9	University of Florida Health Ophthalmology - Jacksonville /ID# 243122	Jacksonville	Florida	United States	32209-6533
10	East Florida Eye Institute /ID# 235762	Stuart	Florida	United States	34994
11	Coastal Research Associates /ID# 234649	Roswell	Georgia	United States	30076
12	Midwest Medical Advisors Inc /ID# 235845	Carmel	Indiana	United States	46290
13	Indiana University - Glick Eye Institute /ID# 235887	Indianapolis	Indiana	United States	46202
14	Johns Hopkins /ID# 236494	Bethesda	Maryland	United States	20817
15	Ophthalmic Consultants of Boston /ID# 236535	Boston	Massachusetts	United States	02129
16	Tekwani Vision Center /ID# 235149	Saint Louis	Missouri	United States	63128
17	Rutgers New Jersey Medical School Campus, Doctors Office Center /ID# 234365	Newark	New Jersey	United States	07103-2425
18	Northern New Jersey Eye Institute PA /ID# 241545	South Orange	New Jersey	United States	07079-1855
19	Asheville Eye Associates /ID# 234963	Asheville	North Carolina	United States	28803
20	James D Branch MD /ID# 234560	Winston-Salem	North Carolina	United States	27101
21	Drs Fine Hoffman & Sims LLC /ID# 235919	Eugene	Oregon	United States	97401
22	Advancing Vision Research /ID# 236683	Smyrna	Tennessee	United States	37167
23	Piedmont Eye Center /ID# 246455	Lynchburg	Virginia	United States	24502
24	Vistar Eye Center /ID# 234811	Roanoke	Virginia	United States	24011
25	Kitasato University Hospital /ID# 238880	Sagamihara-shi	Kanagawa	Japan	252-0375
26	Shimane University Hospital /ID# 238641	Izumo-shi	Shimane	Japan	693-8501
27	The University of Tokyo Hospital /ID# 238871	Bunkyo-ku	Tokyo	Japan	113-8655
28	University of Yamanashi Hospital /ID# 238642	Chuo-shi	Yamanashi	Japan	409-3821