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

NCT ID: NCT04362241

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-07
• Study Completion Date: 2022-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextenza

Sustained release Dexamethasone 0.4mg

Group Type: EXPERIMENTAL

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Intervention Type: DRUG

Prednisolone Acetate 1% ophthalmic drops

Prednisolone Acetate 1%

Prednisolone Acetate Ophthalmic drops

Group Type: ACTIVE_COMPARATOR

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Intervention Type: DRUG

Prednisolone Acetate 1% ophthalmic drops

Interventions

Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

Prednisolone Acetate 1% ophthalmic drops

Intervention Type: DRUG

Other Intervention Names

Prednisolone Acetate 1%

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ophthalmic Consultants of the Capital Region

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Feldman, MD

Role: PRINCIPAL_INVESTIGATOR

Ophthalmic Consultants of the Capital Region

Locations

Ophthalmic Consultants of the Capital Region

Troy, New York, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Suzanne Alterman, RN, BSN

Role: CONTACT

salterman@ophthalmicconsultants.com

518-274-3123

Facility Contacts

Suzanne Alterman, RN, BSN

Role: primary

salterman@ophthalmicconsultants.com

518-274-3123

Other Identifiers

OphthalmicConsultantsOC

Identifier Type: -

Identifier Source: org_study_id