Prospective Study on DEXTENZA® Safety And Efficacy Following Concomitant MIGS and Cataract Surgery (SUSTAIN)

The New York Eye Surgery Center

Status and phase: Terminated; Phase 4

Conditions: Cataract; Glaucoma

Treatments: Drug: Dexamethasone Ophthalmic Insert; Drug: Prednisolone Acetate 1% Oph Susp

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04200651

146602

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

DEXTENZA® arm

Experimental group

Description:

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

Treatment:

Drug: Dexamethasone Ophthalmic Insert

Prednisolone acetate 1% arm

Active Comparator group

Description:

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

Treatment:

Drug: Prednisolone Acetate 1% Oph Susp