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

August 7, 2020 updated by: Ophthalmic Consultants of the Capital Region

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 7 days
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.
Time Frame: 30 days
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.
Time Frame: 60 days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of central subfield thickness (CST) at Day 7 post op as seen on optical coherence tomography (OCT)
Time Frame: 7days
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)
Time Frame: 30 days
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)
Time Frame: 60 days
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%.
Time Frame: 7 days
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%.
Time Frame: 30 days
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%.
Time Frame: 60 days
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%.
Time Frame: 7 days
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%.
Time Frame: 30 days
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%.
Time Frame: 60 days
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
Time Frame: 7 days
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
Time Frame: 30 days
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
Time Frame: 30 days
Percentage of patients who had absence of Anterior Chamber (AC) cells at Day 60
30 days
Self reported patient experience of comfort
Time Frame: 60 days
Self-reported patient experience of comfort (right eye vs. left eye) at Day 60.
60 days
Rescue Therapy
Time Frame: 60 days
Percentage of eyes rescued in each group.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ophthalmic Consultants of the Capital Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert Feldman, MD, Ophthalmic Consultants of the Capital Region

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 7, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 10, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 11, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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