CataractDEXYCURetroNCT04290676

DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001

An observational study of Cataract, run by EyePoint Pharmaceuticals, Inc. at 22 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Cataract
What is being tested?: DEXYCU (dexamethasone intraocular suspension) 9%.
How many people: 527 participants
Where: 22 sitesUnited States
Study dates: 13 Nov 2019to 1 May 2020
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

Subjects who underwent cataract surgery and did not receive DEXYCU

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

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

Other trials in United States

About this study

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

Read the detailed description

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

Conditions: Cataract
Being tested: DEXYCU (dexamethasone intraocular suspension) 9%.
Keywords: DEXYCU, Cataract, dexamethasone intraocular suspension
Medical subject headings: Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DEXYCU (dexamethasone intraocular suspension) 9%.Drug
Also called dexamethasone intraocular suspension
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).

Study groups in NCT04290676
Study group	Role	What they receive
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). Receives: Drug: DEXYCU (dexamethasone intraocular suspension) 9%.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative day 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 20191 May 2020

First posted2 Mar 2020
Study start13 Nov 2019
Primary completion1 May 2020
Study completion1 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for CataractStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Retrospective
Enrolment: 527 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04290676
Sponsor's protocol ID: DEXYCU Retrospective Study 001
Acronym: DEXYCURetro
Status last verified: May 2021
First submitted: 27 Nov 2019
Last updated: 26 May 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cataract trials

Study at a glance

From the registry record, last updated by the sponsor on 26 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001
ClinicalTrials.gov ID: NCT04290676
Acronym / sponsor ID: DEXYCURetro / DEXYCU Retrospective Study 001
Conditions: Cataract
Keywords: DEXYCU, Cataract, dexamethasone intraocular suspension
Study type: Observational
Recruitment status: Completed
Enrolment: 527 participants (actual)
Lead sponsor: EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
Study start: 13 Nov 2019 (actual)
Primary completion: 1 May 2020 (actual)
Study completion: 1 May 2020 (actual)
First posted: 2 Mar 2020 (actual)
Results: Posted 26 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Retrospective study to provide clinical outcomes with 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

Observational model: Other
Time perspective: Retrospective
Number of arms: 1

Arm	Type	Receives
DEXYCU (dexamethasone intraocular suspension) 9%.	–	Drug: 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).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Subjects who underwent cataract surgery from 12Mar2019 to 15Dec2019 and received DEXYCU

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Subjects who underwent cataract surgery and did not receive DEXYCU

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DEXYCU (dexamethasone intraocular suspension) 9%.Also: dexamethasone intraocular suspensionDEXYCU 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).	Drug	DEXYCU (dexamethasone intraocular suspension) 9%.

Primary outcome

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.

Results and safety

Results posted to the registry on 26 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DEXYCU (Dexamethasone Intraocular Suspension) 9%	527	527

Primary outcome: Percentage of Eyes With Anterior Chamber Cell Grade 0

Time frame: Postoperative day 8. Number. Unit: percentage of eyes

Measure	DEXYCU (Dexamethasone Intraocular Suspension) 9% n = 315
Value	65

Population analysed: eyes with a record at postoperative day 8

Adverse events

Time frame: This 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DEXYCU (Dexamethasone Intraocular Suspension) 9%	0 of 527 (0%)	20 of 527 (3.8%)	0 of 527

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dario Paggiarino, MD principal investigator

Senior Vice President, Chief Medical Officer, EyePoint Pharmaceuticals

Keyur Patel, PharmD study chair

Vice President, Medical Affairs, EyePoint Pharmaceuticals

Flavio Leonin, Jr., MD study director

Senior Manager, Clinical Affairs, EyePoint Pharmaceuticals

22 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cataract, run by EyePoint Pharmaceuticals, Inc. at 22 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Eyes With Anterior Chamber Cell Grade 0 (time frame: Postoperative day 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04290676.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2021.