DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

NCT04290676 | Completed Results FDA Drug

• 1 other identifier: DEXYCU Retrospective Study 001
• Study Type: observational
• Target: 527
• Locations: 1 country
• Sites: 22

Brief Summary

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

Conditions

Cataract

Keywords

DEXYCU; Cataract; dexamethasone intraocular suspension

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With Anterior Chamber Cell Grade 0

  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

Study Arms (1)

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%.

Interventions

DEXYCU (dexamethasone intraocular suspension) 9%. 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).

Also known as: dexamethasone intraocular suspension

DEXYCU (dexamethasone intraocular suspension) 9%.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Subjects who underwent cataract surgery and did not receive DEXYCU

Sponsors & Collaborators

• EyePoint Pharmaceuticals, Inc.: lead

Study Sites (22)

Eye Center South Locations

Dothan, Alabama, 36301, United States

Location

Inland Eye Specialists

Hemet, California, 92545, United States

Location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

Location

Coastal Vision Medical Group

Orange, California, 92868, United States

Location

North Bay Eye Associates, Inc.

Rohnert Park, California, 94928, United States

Location

The Eye Associates of Manatee, LLP

Bradenton, Florida, 34209, United States

Location

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

Largo, Florida, 33770, United States

Location

Jacksoneye, SC

Lake Villa, Illinois, 60046, United States

Location

Hauser-Ross Eye Institute

Oak Brook, Illinois, 60523, United States

Location

Price Vision Group

Indianapolis, Indiana, 46260, United States

Location

Physicians Eyecare Center

Baltimore, Maryland, 21229, United States

Location

Discover Vision Centers

Independence, Missouri, 64055, United States

Location

Silverstein Eye Centers

Kansas City, Missouri, 64133, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63128, United States

Location

Surgery Center of Central New Jersey

Pennington, New Jersey, 08534, United States

Location

SightMD, PLLC

Hauppauge, New York, 11788, United States

Location

New York Eye Surgery Center

The Bronx, New York, 10469, United States

Location

Island Eye Surgicenter

Westbury, New York, 11590, United States

Location

Wills Surgery Center

Jenkintown, Pennsylvania, 19046, United States

Location

VRF Eye Specialty Group

Memphis, Tennessee, 38120, United States

Location

Valley Retina Institute, PA

McAllen, Texas, 78503, United States

Location

The Eye Centers of Racine and Kenosha

Racine, Wisconsin, 53405, United States

Location

MeSH Terms

Conditions

Cataract

Interventions

Calcium Dobesilate

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Results Point of Contact

• Title: Dario Paggiarino, MD
• Organization: EyePoint Pharmaceuticals

dpaggiarino@eyepointpharma.com

(617) 610-3411

Study Officials

• Dario Paggiarino, MD

  Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals

  PRINCIPAL INVESTIGATOR

• Keyur Patel, PharmD

  Vice President, Medical Affairs, EyePoint Pharmaceuticals

  STUDY CHAIR

• Flavio Leonin, Jr., MD

  Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2019
• First Posted: March 2, 2020
• Study Start: November 13, 2019
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)