DEXTENZA VS. PREDNISOLONE ACETATE 1% Macular Edema With Diabetic Retinopathy After Cataract Surgery

Ophthalmic Consultants of the Capital Region

Status and phase: Unknown; Phase 4

Conditions: Retinopathy, Diabetic

Treatments: Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Study type: Interventional

Funder types: Other

Identifiers

NCT04362241

OphthalmicConsultantsOC

Details and patient eligibility

About

The complicated schedules for administering topical steroid eye drops combined with forgetfulness and physical difficulties instilling the drops may compromise compliance; which in turn could increase the risk for secondary complications such as PME post-cataract surgery, especially in a high-risk diabetic population. Dextenza, a sustained- release steroid insert, could help preclude adherence difficulties and provide better bioavailability, being as effective as, or more effective than steroid drops in preventing PME. The aim of this study is to assess the incidence of PME in diabetic patients undergoing cataract surgery when comparing the Dextenza insert to topical prednisolone acetate 1% drops.

Full description

This prospective, open-label, single-center, randomized, fellow-eye, investigator-sponsored clinical study seeks to investigate the incidence of PME in diabetic patients with any level of background diabetic retinopathy undergoing cataract surgery treated with a 0.4mg dexamethasone intracanalicular insert when compared to standard of care prednisolone acetate 1% QID/1 week, TID/ 1 week, BID/ 1 week, QD/1 week. Topical NSAIDs will not be used in this study and all patients will receive an intracameral injection of moxifloxacin at the end of the surgical procedure. After screening a patient for inclusion and exclusion criteria, and gaining informed consent, each eye will undergo cataract surgery on separate days. The second eye will be operated on within 60 days of the first eye's surgery. One eye will be randomized to receive the dexamethasone insert using a coin flip. The other eye will be prescribed a prednisolone acetate 0.1% eye drop QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen. The dexamethasone insert will be placed 2-4 days before surgery (Day -4 to Day-2) and those randomized to receive prednisolone acetate will start 2-4 days before surgery. After surgery, each eye will be followed for a period of approximately 60 days, consisting of four post-op follow-up visits (eight total post-op visits per patient). Primary and secondary endpoints will be assessed alongside standard-of-care procedures at all study visits . Adjusting for the enrollment period, the study will last a total of approximately 12 months.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Binocular
• >18 years old
• Any level of Background Diabetic Retinopathy
• Cataract surgery candidate in each eye
• Pre-operative OCT and Fluorescein Angiography showing no Macular edema

Exclusion criteria

• Participant cannot complete second eye operation within 60 days of the first cataract surgery
• Maintains regular use of systemic or ocular steroids at time of enrollment
• Maintains regular use of systemic or ocular non-steroidal anti-inflammatory drugs at time of enrollment
• Anterior chamber cells present at time of enrollment
• Recent febrile illness that precludes or delays participation for 90 days
• Pregnancy or lactation
• Known allergy to dexamethasone
• Known allergy to prednisolone
• Preexisting retinal disease including uveitis, nondiabetic retinal disease, choroidal disorders, diabetic macular edema.
• Posterior capsule rupture or other intraoperative complication in first eye operated on
• Amblyopia
• Anti-VEGF injections within 6 months prior to surgery day.
• Intraocular steroid injection within 6 months prior to surgery day.
• Intraocular surgeries within 6 months prior to surgery day.
• Laser photocoagulation within 30 days prior to surgery day.
• Any type of eye inflammation
• Any punctum inflammation or dacryocystitis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Dextenza

Experimental group

Description:

Sustained release Dexamethasone 0.4mg

Treatment:

Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Prednisolone Acetate 1%

Active Comparator group

Description:

Prednisolone Acetate Ophthalmic drops

Treatment:

Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]