Clinical trial NCT04200651: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Official title: Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Glaucoma
Cataract
Keywords: MIGS, Minimally invasive glaucoma surgery
Lead sponsor: The New York Eye Surgery Center
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2019-12-16
Enrollment: 25
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This prospective study enrolled 29 eyes from 25 total patients. The protocol permitted some binocular enrollment from patients who met eligibility criteria in both eyes.

All eligible eyes received concomitant cataract and MIGS surgery. Each eye was randomized to receive either DEXTENZA® insertion at the end of the surgery or to a standard of care prednisolone acetate 1% eye drop regimen via block randomization. All eyes received the standard of care topical ofloxacin antibiotic regimen. The experimental group consisted of the eyes receiving DEXTENZA® insertion. The control group consisted of the eyes placed on the prednisolone eye drop regimen.
Primary purpose: TREATMENT

Brief summary: In this study, the investigators are comparing dexamethasone ophthalmic insert (DEXTENZA®) to the current standard of care, prednisolone acetate 1% eye drops, in a glaucoma population receiving both cataract and minimally-invasive glaucoma surgery (MIGS). DEXTENZA® and prednisolone acetate 1% drops are both steroids used to control inflammation after eye surgery. DEXTENZA®'s method of delivery differs by offering a sustained release of steroid that does not necessitate postoperative anti-inflammatory eye drops. 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. The investigators also hypothesize that DEXTENZA® will be preferred by patients over prednisolone acetate 1% drops.

Detailed description: Glaucoma and cataract surgery patients face an outsize postoperative burden. In addition to taking frequent anti-inflammatory eye drops, they often continue their glaucoma medications. This can cause patient confusion and nonadherence, potentially leading to poor healing, slower recovery period, and/or cystoid macular edema. DEXTENZA®, as a sustained release anti-inflammatory insert, could help preclude adherence difficulties and increase comfort by reducing eye drop load. However, glaucoma surgeons may hesitate to adopt DEXTENZA® due to concerns regarding safety with respect to elevated intraocular pressure. This prospective study will address those concerns directly, providing timely and high-quality clinical evidence comparing DEXTENZA® to standard-of-care steroid eye drops. For physicians and patients, the results of this study will prove immediately useful for therapeutic decision-making.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Maintains regular use (daily or more) of systemic or ocular steroids at time of enrollment
* Maintains regular use (daily or more) of systemic or ocular nonsteroidal anti-inflammatory drugs at time of enrollment
* Anterior chamber cells present at time of enrollment
* Recent febrile illness that precludes or delays participation for 3 months
* Pregnancy or lactation
* Known allergy to dexamethasone
* Known allergy to prednisolone
* Treatment with another investigational drug within the last 20 years
* Current recreational drug use
* Preexisting ocular pathology likely to confound the visual acuity or comfort endpoints including but not limited to: severe corneal scarring, ocular surface disease, diabetic retinopathy, or macular edema
* Corneal or retinal procedures (laser or incisional) during the study period and 6 months prior

Primary outcomes:
measure: Change in Intraocular Pressure (IOP) at 1 and 3 Months
timeFrame: 1 month postop, 3 months postop
measure: Change in Best-corrected Visual Acuity (BCVA) at 1 and 3 Months
timeFrame: 1 month postop, 3 months postop
measure: Difference in Eyes With Adverse Events Between Groups
timeFrame: Up to 3 months postop
measure: Difference in Number of Glaucoma Medications at 3 Months
timeFrame: 3 months postop
Secondary outcomes:
measure: Percentage of Eyes Requiring Supplemental Prednisolone Acetate 1% Eye Drops
timeFrame: Up to 3 months postop
measure: Number of Eyes With Presenting With Cystoid Macular Edema (CME) as Seen on Optical Coherence Tomography (OCT)
timeFrame: 3 months postop
measure: Difference in Ocular Comfort Index (OCI) Score at 1 Month
timeFrame: 1 month postop
measure: Difference in Ocular Comfort Index (OCI) Score at 3 Months
timeFrame: 3 months postop
measure: Difference in Number of Eyes With Absence of Anterior Chamber (AC) Cells at 1 Month
timeFrame: 1 month postop
Other outcomes:
Locations:
city: Bronx
country: United States
facility: The New York Eye Surgery Center
state: New York
Study officials:
affiliation: New York Eye Surgery Center; New York Eye and Ear Infirmary of Mount Sinai
name: Nathan M Radcliffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Johnson ME, Murphy PJ. Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index. Invest Ophthalmol Vis Sci. 2007 Oct;48(10):4451-8. doi: 10.1167/iovs.06-1253.
citation: Juthani VV, Clearfield E, Chuck RS. Non-steroidal anti-inflammatory drugs versus corticosteroids for controlling inflammation after uncomplicated cataract surgery. Cochrane Database Syst Rev. 2017 Jul 3;7(7):CD010516. doi: 10.1002/14651858.CD010516.pub2.
citation: Kindle T, Ferguson T, Ibach M, Greenwood M, Schweitzer J, Swan R, Sudhagoni RG, Berdahl JP. Safety and efficacy of intravitreal injection of steroid and antibiotics in the setting of cataract surgery and trabecular microbypass stent. J Cataract Refract Surg. 2018 Jan;44(1):56-62. doi: 10.1016/j.jcrs.2017.10.040.
citation: Newman-Casey PA, Robin AL, Blachley T, Farris K, Heisler M, Resnicow K, Lee PP. The Most Common Barriers to Glaucoma Medication Adherence: A Cross-Sectional Survey. Ophthalmology. 2015 Jul;122(7):1308-16. doi: 10.1016/j.ophtha.2015.03.026. Epub 2015 Apr 24.
citation: Fisher BL, Potvin R. Transzonular vitreous injection vs a single drop compounded topical pharmaceutical regimen after cataract surgery. Clin Ophthalmol. 2016 Jul 18;10:1297-303. doi: 10.2147/OPTH.S112080. eCollection 2016.