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

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

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cataract	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

Arm	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

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

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

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)

• Study Protocol and Statistical Analysis Plan - Oct 15, 2019

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.: DEXYCU; Cataract; dexamethasone intraocular suspension
• Additional relevant MeSH terms: Cataract; Dexamethasone; Dexamethasone acetate; BB 1101

Study Results

Participant Flow

Arm/Group Title	DEXYCU (Dexamethasone Intraocular Suspension) 9%
Arm/Group Description	All 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
STARTED	527
COMPLETED	527
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	DEXYCU (Dexamethasone Intraocular Suspension) 9%
Arm/Group Description	All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
Overall Participants	527
Overall eyes	641
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

Title	Percentage of Eyes With Anterior Chamber Cell Grade 0
Description	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.
Time Frame	Postoperative day 8

Outcome Measure Data

Analysis Population Description

eyes with a record at postoperative day 8

Arm/Group Title	DEXYCU (Dexamethasone Intraocular Suspension) 9%
Arm/Group Description	All participants received DEXYCU (dexamethasone intraocular suspension) 9% as a single dose, administered intraocularly into the posterior chamber at the end of surgery.
Measure Participants	315
Measure eyes	315
Number [percentage of eyes]	65

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.
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 Title	DEXYCU (Dexamethasone Intraocular Suspension) 9%
Arm/Group Description	All 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
Total	0/527 (0%)
Serious Adverse Events
	DEXYCU (Dexamethasone Intraocular Suspension) 9%
	Affected / at Risk (%)	# Events
Total	0/527 (0%)
Other (Not Including Serious) Adverse Events
	DEXYCU (Dexamethasone Intraocular Suspension) 9%
	Affected / at Risk (%)	# Events
Total	20/527 (3.8%)
Eye disorders
Corneal edema	5/527 (0.9%)	6
Iritis	4/527 (0.8%)	4
Vision blurred	1/527 (0.2%)	1
Retina peripheral hole	1/527 (0.2%)	1
Hypotony maculopathy	1/527 (0.2%)	1
Retained cortex in anterior chamber	1/527 (0.2%)	1
Investigations
Intraocular pressure increased	6/527 (1.1%)	7
Product Issues
DEXYCU on lens optic	1/527 (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.