NCT04362241

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

DEXTENZA VS. PREDNISOLONE ACETATE 1% in the Incidence of Pseudophakic Macular Edema in Patients With Diabetic Retinopathy Undergoing Cataract Surgery

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Ophthalmic Consultants of the Capital Region · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Retinopathy, Diabetic

Interventions

Type	Name	Description
DRUG	Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]	Prednisolone Acetate 1% ophthalmic drops

Timeline

• Start date: 2020-08-07
• Primary completion: 2022-02-01
• Completion: 2022-03-01
• First posted: 2020-04-24
• Last updated: 2020-08-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study