DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

NCT ID: NCT04290676

Last Updated: 2021-05-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

527 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-13

Study Completion Date

2020-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cataract

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

DEXYCU (dexamethasone intraocular suspension) 9%.

Intervention Type DRUG

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).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

dexamethasone intraocular suspension

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EyePoint Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Dario Paggiarino, MD

Role: PRINCIPAL_INVESTIGATOR

Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals

Keyur Patel, PharmD

Role: STUDY_CHAIR

Vice President, Medical Affairs, EyePoint Pharmaceuticals

Flavio Leonin, Jr., MD

Role: STUDY_DIRECTOR

Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eye Center South Locations

Dothan, Alabama, United States

Site Status

Inland Eye Specialists

Hemet, California, United States

Site Status

Harvard Eye Associates

Laguna Hills, California, United States

Site Status

Coastal Vision Medical Group

Orange, California, United States

Site Status

North Bay Eye Associates, Inc.

Rohnert Park, California, United States

Site Status

The Eye Associates of Manatee, LLP

Bradenton, Florida, United States

Site Status

Eye Physicians of Pinellas, PA, dba The Eye Institute of West Florida

Largo, Florida, United States

Site Status

Jacksoneye, SC

Lake Villa, Illinois, United States

Site Status

Hauser-Ross Eye Institute

Oak Brook, Illinois, United States

Site Status

Price Vision Group

Indianapolis, Indiana, United States

Site Status

Physicians Eyecare Center

Baltimore, Maryland, United States

Site Status

Discover Vision Centers

Independence, Missouri, United States

Site Status

Silverstein Eye Centers

Kansas City, Missouri, United States

Site Status

Tekwani Vision Center

St Louis, Missouri, United States

Site Status

Surgery Center of Central New Jersey

Pennington, New Jersey, United States

Site Status

SightMD, PLLC

Hauppauge, New York, United States

Site Status

New York Eye Surgery Center

The Bronx, New York, United States

Site Status

Island Eye Surgicenter

Westbury, New York, United States

Site Status

Wills Surgery Center

Jenkintown, Pennsylvania, United States

Site Status

VRF Eye Specialty Group

Memphis, Tennessee, United States

Site Status

Valley Retina Institute, PA

McAllen, Texas, United States

Site Status

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

DEXYCU Retrospective Study 001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PREFERENTIAL Study
NCT04563559 WITHDRAWN PHASE2/PHASE3