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

Sponsor
EyePoint Pharmaceuticals, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04290676
Collaborator
(none)
527
Enrollment
22
Locations
5.6
Actual Duration (Months)
24
Patients Per Site
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Retrospective study to provide clinical outcomes with DEXYCU (dexamethasone intraocular suspension) 9%.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: DEXYCU (dexamethasone intraocular suspension) 9%.

Detailed Description

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

Study Design

Study Type:
Observational
Actual Enrollment :
527 participants
Observational Model:
Other
Time Perspective:
Retrospective
Official Title:
DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
Actual Study Start Date :
Nov 13, 2019
Actual Primary Completion Date :
May 1, 2020
Actual Study Completion Date :
May 1, 2020

Arms and Interventions

ArmIntervention/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
  • Outcome Measures

    Primary Outcome Measures

    1. Percentage of Eyes With Anterior Chamber Cell Grade 0 [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Eye Center South LocationsDothanAlabamaUnited States36301
    2Inland Eye SpecialistsHemetCaliforniaUnited States92545
    3Harvard Eye AssociatesLaguna HillsCaliforniaUnited States92653
    4Coastal Vision Medical GroupOrangeCaliforniaUnited States92868
    5North Bay Eye Associates, Inc.Rohnert ParkCaliforniaUnited States94928
    6The Eye Associates of Manatee, LLPBradentonFloridaUnited States34209
    7Eye Physicians of Pinellas, PA, dba The Eye Institute of West FloridaLargoFloridaUnited States33770
    8Jacksoneye, SCLake VillaIllinoisUnited States60046
    9Hauser-Ross Eye InstituteOak BrookIllinoisUnited States60523
    10Price Vision GroupIndianapolisIndianaUnited States46260
    11Physicians Eyecare CenterBaltimoreMarylandUnited States21229
    12Discover Vision CentersIndependenceMissouriUnited States64055
    13Silverstein Eye CentersKansas CityMissouriUnited States64133
    14Tekwani Vision CenterSaint LouisMissouriUnited States63128
    15Surgery Center of Central New JerseyPenningtonNew JerseyUnited States08534
    16New York Eye Surgery CenterBronxNew YorkUnited States10469
    17SightMD, PLLCHauppaugeNew YorkUnited States11788
    18Island Eye SurgicenterWestburyNew YorkUnited States11590
    19Wills Surgery CenterJenkintownPennsylvaniaUnited States19046
    20VRF Eye Specialty GroupMemphisTennesseeUnited States38120
    21Valley Retina Institute, PAMcAllenTexasUnited States78503
    22The Eye Centers of Racine and KenoshaRacineWisconsinUnited States53405

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    EyePoint Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04290676
    Other Study ID Numbers:
    • DEXYCU Retrospective Study 001
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    May 26, 2021
    Last Verified:
    May 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by EyePoint Pharmaceuticals, Inc.
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group TitleDEXYCU (Dexamethasone Intraocular Suspension) 9%
    Arm/Group DescriptionAll participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
    Period Title: Overall Study
    STARTED527
    COMPLETED527
    NOT COMPLETED0

    Baseline Characteristics

    Arm/Group TitleDEXYCU (Dexamethasone Intraocular Suspension) 9%
    Arm/Group DescriptionAll participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
    Overall Participants527
    Overall eyes641
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    71.5
    (8.35)
    Sex: Female, Male (Count of Participants)
    Female
    308
    58.4%
    Male
    219
    41.6%
    Race/Ethnicity, Customized (Count of Participants)
    Hispanic or Latino
    74
    14%
    Not Hispanic or Latino
    327
    62%
    Not Reported
    100
    19%
    Unknown
    26
    4.9%

    Outcome Measures

    1. Primary Outcome
    TitlePercentage of Eyes With Anterior Chamber Cell Grade 0
    DescriptionOf 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.
    Time FramePostoperative day 8

    Outcome Measure Data

    Analysis Population Description
    eyes with a record at postoperative day 8
    Arm/Group TitleDEXYCU (Dexamethasone Intraocular Suspension) 9%
    Arm/Group DescriptionAll participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
    Measure Participants315
    Measure eyes315
    Number [percentage of eyes]
    65

    Adverse Events

    Time FrameThis was a retrospective observational study based on chart review of patients in real-world clinical settings receiving DEXYCU after cataract surgery between 12 March and 15 December 2019. Data from patient charts were entered retrospectively by the study coordinator or other designated, trained personnel at study sites into a password-protected database, for the day of surgery and for postoperative days 1, 8, 14, and 30, as available.
    Adverse Event Reporting Description All adverse events reported by investigators are included, irrespective of whether or not the event was present prior to intraocular administration of DEXYCU at the end of cataract surgery.
    Arm/Group TitleDEXYCU (Dexamethasone Intraocular Suspension) 9%
    Arm/Group DescriptionAll participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
    All Cause Mortality
    DEXYCU (Dexamethasone Intraocular Suspension) 9%
    Affected / at Risk (%)# Events
    Total0/527 (0%)
    Serious Adverse Events
    DEXYCU (Dexamethasone Intraocular Suspension) 9%
    Affected / at Risk (%)# Events
    Total0/527 (0%)
    Other (Not Including Serious) Adverse Events
    DEXYCU (Dexamethasone Intraocular Suspension) 9%
    Affected / at Risk (%)# Events
    Total20/527 (3.8%)
    Eye disorders
    Corneal edema5/527 (0.9%) 6
    Iritis4/527 (0.8%) 4
    Vision blurred1/527 (0.2%) 1
    Retina peripheral hole1/527 (0.2%) 1
    Hypotony maculopathy1/527 (0.2%) 1
    Retained cortex in anterior chamber1/527 (0.2%) 1
    Investigations
    Intraocular pressure increased6/527 (1.1%) 7
    Product Issues
    DEXYCU on lens optic1/527 (0.2%) 1

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    During the Study and for a period of ten (10) years after completion or early termination of the Multi-Center Retrospective Trial, without Sponsor's and/or its representative prior written consent, Institution and Investigator will not publish, disseminate or otherwise disclose, deliver or make available any Confidential Information to any third party other than Study Personnel or Sponsor's representative, and then only for the purpose of conducting the Study.

    Results Point of Contact

    Name/TitleDario Paggiarino, MD
    OrganizationEyePoint Pharmaceuticals
    Phone(617) 610-3411
    Emaildpaggiarino@eyepointpharma.com
    Responsible Party:
    EyePoint Pharmaceuticals, Inc.
    ClinicalTrials.gov Identifier:
    NCT04290676
    Other Study ID Numbers:
    • DEXYCU Retrospective Study 001
    First Posted:
    Mar 2, 2020
    Last Update Posted:
    May 26, 2021
    Last Verified:
    May 1, 2021