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Corticosteroid

Dexamethasone Ophthalmic Insert for Glaucoma (SUSTAIN Trial)

Phase 4

Waitlist Available

Led By Nathan M Radcliffe, MD

Research Sponsored by The New York Eye Surgery Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cataract surgery candidate and glaucoma present in at least one eye

Minimally-invasive glaucoma surgery candidate in that same eye. Defined by having ocular hypertension requiring a medication, OR as by having mild, moderate, or severe glaucoma that is sufficiently stable and appropriate for operation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month postop, 3 months postop

Awards & highlights

SUSTAIN Trial Summary

This trial is comparing the safety and effectiveness of two different steroids, DEXTENZA® and prednisolone acetate 1%, in controlling inflammation after eye surgery. The investigators hypothesize that DEXTENZA® will be as safe as prednisolone acetate 1% drops and as effective at controlling postoperative inflammation following concomitant cataract-MIGS in a glaucoma population.

Eligible Conditions

Glaucoma
Cataract

SUSTAIN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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You have cataracts and glaucoma in at least one eye, and you are planning to have cataract surgery.

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You have high eye pressure or glaucoma that can be managed with medication or surgery.

SUSTAIN Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month postop, 3 months postop

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month postop, 3 months postop

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month postop, 3 months postop for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months

Change in Intraocular Pressure (IOP) at 1 and 3 Months

Difference in Eyes With Adverse Events Between Groups

+1 more

Secondary outcome measures

Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month

Difference in Ocular Comfort Index (OCI) Score at 1 Month

Difference in Ocular Comfort Index (OCI) Score at 3 Months

+2 more

SUSTAIN Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: DEXTENZA® armExperimental Treatment1 Intervention

This arm will receive the DEXTENZA® insert after cataract surgery and MIGS.

Group II: Prednisolone acetate 1% armActive Control1 Intervention

This arm will receive the prescription for daily prednisolone acetate 1% eye drops after cataract surgery and MIGS.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The New York Eye Surgery CenterLead Sponsor

Ocular Therapeutix, Inc.Industry Sponsor

53 Previous Clinical Trials

5,552 Total Patients Enrolled

6 Trials studying Glaucoma

802 Patients Enrolled for Glaucoma

Nathan M Radcliffe, MDPrincipal InvestigatorNew York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What goals is this research endeavor seeking to accomplish?

"According to the trial sponsor, Ocular Therapeutix, Inc., they will be measuring a variety of primary and secondary objectives within a 3 month period. The most prominent metric is Change in Best-Corrected Visual Acuity (BCVA) at 1 & 3 months postop but other criteria include Percentage of patients requiring supplemental prednisolone acetate 1% eye drops for anti-inflammatory rescue, incidence of cystoid macular edema as seen on optical coherence tomography scans, and difference in Ocular Comfort Index score at one month. This last measurement has an assessment range between 0 - 100 with higher numbers sign"

Answered by AI

What clinical indications does Dexamethasone Ophthalmic Insert typically treat?

"Dexamethasone Ophthalmic Insert is regularly administered for the treatment of ophthalmia, sympathetic. This medication can also be beneficial in addressing branch retinal vein occlusion, various eye infections, bacterial afflictions and macular edema."

Answered by AI

Has the FDA validated Dexamethasone Ophthalmic Insert?

"The safety of Dexamethasone Ophthalmic Insert is confirmed by the fact that this medication has reached Phase 4 in its testing process, thus receiving a score of 3."

Answered by AI

How many individuals are actively participating in this clinical experimentation?

"Affirmative, clinicaltrials.gov reveals that this research is currently seeking participants for its investigation. First appearing on January 13th 2020, the trial was recently updated on March 20th 2022 and requires 40 individuals from a single medical centre to take part."

Answered by AI

Are there available positions for participants in this investigation?

"Affirmative. The clinicaltrials.gov page indicates that this investigation, which went live on January 13th 2020, is actively looking for recruits. 40 participants need to be sourced from one medical centre."

Answered by AI

Have previous investigations examined the effects of Dexamethasone Ophthalmic Insert?

"Presently, a total of 556 trials are underway investigating Dexamethasone Ophthalmic Insert. Of those in progress, 145 have reached Phase 3 and most are located in Mishawaka, Indiana; however, there are an additional 18626 centres running similar studies for this medication."

Answered by AI

Recent research and studies

Clinical OphthalmologyJournal

Transzonular Vitreous Injection Vs a Single Drop Compounded Topical Pharmaceutical Regimen After Cataract Surgery

Potvin, Rick, and Bret Fisher. 2016. “Transzonular Vitreous Injection Vs a Single Drop Compounded Topical Pharmaceutical Regimen After Cataract Surgery”. Clinical Ophthalmology. Informa UK Limited. doi:10.2147/opth.s112080.

Investigative Opthalmology & Visual ScienceJournal

Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index

Johnson, Michael E., and Paul J. Murphy. 2007. “Measurement of Ocular Surface Irritation on a Linear Interval Scale with the Ocular Comfort Index”. Investigative Opthalmology & Visual Science. Association for Research in Vision and Ophthalmology (ARVO). doi:10.1167/iovs.06-1253.

Journal of Cataract and Refractive SurgeryJournal

Safety and Efficacy of Intravitreal Injection of Steroid and Antibiotics in the Setting of Cataract Surgery and Trabecular Microbypass Stent

Kindle, Trevor, Tanner Ferguson, Mitch Ibach, Michael Greenwood, Justin Schweitzer, Russell Swan, Ramu G. Sudhagoni, and John P. Berdahl. 2018. “Safety and Efficacy of Intravitreal Injection of Steroid and Antibiotics in the Setting of Cataract Surgery and Trabecular Microbypass Stent”. Journal of Cataract and Refractive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/j.jcrs.2017.10.040.

OphthalmologyJournal