DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 (DEXYCURetro)

May 24, 2021 updated by: EyePoint Pharmaceuticals, Inc.
Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This retrospective study is intended to provide large-scale, real-world data on clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Study Type

Observational

Enrollment (Actual)

527

Contacts and Locations

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

Study Locations

  • United States
    • Alabama
      • Dothan, Alabama, United States, 36301
        • Eye Center South Locations
    • California
      • Hemet, California, United States, 92545
        • Inland Eye Specialists
      • Laguna Hills, California, United States, 92653
        • Harvard Eye Associates
      • Orange, California, United States, 92868
        • Coastal Vision Medical Group
      • Rohnert Park, California, United States, 94928
        • North Bay Eye Associates, Inc.
    • Florida
      • Bradenton, Florida, United States, 34209
        • The Eye Associates of Manatee, LLP
      • Largo, Florida, United States, 33770
        • Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida
    • Illinois
      • Lake Villa, Illinois, United States, 60046
        • Jacksoneye, SC
      • Oak Brook, Illinois, United States, 60523
        • Hauser-Ross Eye Institute
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Price Vision Group
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Physicians Eyecare Center
    • Missouri
      • Independence, Missouri, United States, 64055
        • Discover Vision Centers
      • Kansas City, Missouri, United States, 64133
        • Silverstein Eye Centers
      • Saint Louis, Missouri, United States, 63128
        • Tekwani Vision Center
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Surgery Center of Central New Jersey
    • New York
      • Bronx, New York, United States, 10469
        • New York Eye Surgery Center
      • Hauppauge, New York, United States, 11788
        • SightMD, PLLC
      • Westbury, New York, United States, 11590
        • Island Eye Surgicenter
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • Wills Surgery Center
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • VRF Eye Specialty Group
    • Texas
      • McAllen, Texas, United States, 78503
        • Valley Retina Institute, PA
    • Wisconsin
      • Racine, Wisconsin, United States, 53405
        • The Eye Centers of Racine and Kenosha

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Description

Inclusion Criteria

  • Male and Female subjects at least 18 years of age
  • Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Exclusion Criteria

• Subjects who underwent cataract surgery and did not receive DEXYCU

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

  • Observational Models: Other
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DEXYCU (dexamethasone intraocular suspension) 9%.
DEXYCU (dexamethasone intraocular suspension) 9%. Single dose, intraocularly in the posterior chamber at the end of surgery. The dose is 0.005 mL of dexamethasone 9% (equivalent to 517 micrograms).
Drug: DEXYCU (dexamethasone intraocular suspension) 9%.
DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).
Other Names:
  • dexamethasone intraocular suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Eyes With Anterior Chamber Cell Grade 0
Time Frame: Postoperative day 8
Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam.
Postoperative day 8

Collaborators and Investigators

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

Sponsor

EyePoint Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Dario Paggiarino, MD, Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals
  • Study Chair: Keyur Patel, PharmD, Vice President, Medical Affairs, EyePoint Pharmaceuticals
  • Study Director: Flavio Leonin, Jr., MD, Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals

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)

November 13, 2019

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

November 27, 2019

First Submitted That Met QC Criteria

February 26, 2020

First Posted (Actual)

March 2, 2020

Study Record Updates

Last Update Posted (Actual)

May 26, 2021

Last Update Submitted That Met QC Criteria

May 24, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEXYCU Retrospective Study 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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