DocTrials | Walman Eye Center
Status and phase
Conditions
Treatments
About
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
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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):
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).
Primary purpose
Allocation
Interventional model
Masking
96 participants in 6 patient groups
Loading...
Central trial contact
ABBVIE CALL CENTER
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal