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

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.

Study Overview

• Status: Unknown
• Conditions: Retinopathy, Diabetic
• Intervention / Treatment: Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Suzanne Alterman, RN, BSN; Phone Number: 518-274-3123; Email: salterman@ophthalmicconsultants.com

Study Locations

• United States
  • New York
    • Troy, New York, United States, 12180
      • Recruiting
      • Ophthalmic Consultants of the Capital Region
      • Contact: Suzanne Alterman, RN, BSN; Phone Number: 518-274-3123; Email: salterman@ophthalmicconsultants.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dextenza; Sustained release Dexamethasone 0.4mg	Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]; Prednisolone Acetate 1% ophthalmic drops; Other Names: Prednisolone Acetate 1%
Active Comparator: Prednisolone Acetate 1%; Prednisolone Acetate Ophthalmic drops	Drug: Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]; Prednisolone Acetate 1% ophthalmic drops; Other Names: Prednisolone Acetate 1%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.	Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 7 on Optical Coherence Tomography at Day 7 by a masked grader.	7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.	Percentage of eyes that developed post-surgical PME in each group measured on optical coherence tomography at Day 30 by a masked grader.	30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in preventing PME in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1% as measure.	Percentage of eyes that developed post-surgical PME in each group measured on fluorescein angiography at Day 60 and on optical coherence tomography at Day 60 by a masked grader.	60 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)	Mean central subfield thickness (CST) at Day 7 post op in each group and comparison between groups.	7days
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)	Mean central subfield thickness (CST) at Day 30 post op in each group and comparison between groups.	30 days
Incidence of central subfield thickness (CST) at Day 60 post op as seen on optical coherence tomography (OCT)	Mean central subfield thickness (CST) at Day 60 post op in each group and comparison between groups.	60 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.	Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.	7 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.	Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.	30 days
To measure the change in CST inflammation outcomes and in diabetic patients as seen on optical coherence tomography (OCT), Dextenza compared to topical prednisolone acetate 1%.	Mean change in CST from Baseline at Day 7, Day 30 and Day 60 and comparison between groups.	60 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.	Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 7 post op	7 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.	Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 30 post op	30 days
To measure the effect of 0.4mg dexamethasone intracanalicular insert in vision in diabetic patients undergoing cataract surgery when compared to topical prednisolone acetate 1%.	Difference of mean ETDRS Best Corrected Visual Acuity (BCVA) between groups at Day 60 post op	60 days
Difference patients with absence of anterior chamber (AC) cells at Day 7 post op	Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 7	7 days
Difference patients with absence of anterior chamber (AC) cells at Day 30 post op	Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 30	30 days
Difference patients with absence of anterior chamber (AC) cells at Day 60 post op	Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 60	30 days
Self reported patient experience of comfort	Self-reported patient experience of comfort (right eye vs. left eye) at Day 60.	60 days
Rescue Therapy	Percentage of eyes rescued in each group.	60 days

Collaborators and Investigators

• Sponsor: Ophthalmic Consultants of the Capital Region
• Investigators: Principal Investigator: Robert Feldman, MD, Ophthalmic Consultants of the Capital Region

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2020
• Primary Completion (Anticipated): February 1, 2022
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 23, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): August 11, 2020
• Last Update Submitted That Met QC Criteria: August 7, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Retinal Degeneration; Macular Degeneration; Lens Diseases; Retinal Diseases; Diabetic Retinopathy; Macular Edema; Cataract; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
• Other Study ID Numbers: OphthalmicConsultantsOC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No