DEXTENZA in Pediatric Patients Following Retinal Surgery... | NCT05620901

NCT05620901

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment Arm	Experimental	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively	Drug: Dextenza 0.4Mg Ophthalmic Insert
Control Arm	Active Comparator	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.	Drug: Pred Forte

Name	Type	Description	Arm Group Labels	Other Names
Dextenza 0.4Mg Ophthalmic Insert	Drug	DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use	Treatment Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain as Measured by the FLACC Pain Scale	The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.	Baseline, post-op days 1, 7, 28, and 45

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants With Adverse Events	Adverse events are addressed/ assessed at each visit	Up to post-op day 45
Severity of Adverse Events	Adverse events are addressed/ assessed at each visit

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to:

Conditions:

Familial Exudative Vitreoretinopathy
Coats' Disease
Exudative Retinopathy
Lattice degeneration
Retinal holes
Sickler's syndrome
Retinal detachment, rhegmatogenous
Retinal detachment, exudative
Retinal detachment, tractional

Procedures

Laser photocoagulation
Cryotherapy
Retinal detachment repair with scleral buckle and cryotherapy
Retinal detachment repair with vitrectomy
Written informed consent from parent/legal guardian

Exclusion Criteria:

Preprocedural

Active or history of chronic or recurrent inflammatory eye disease in either eye
Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing
Active or history of increased ocular pressure
Patients with active corneal, conjunctival, and canalicular infections
Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion
Nasolacrimal duct obstruction
Laser or incisional ocular surgery during the study period and 6 months prior in the study eye
current use of systemic or topical steroids or NSAIDS on a regular basis
History of autoimmune disease that may interfere with treatment/outcomes
Ocular pain at the time of screening
Known malignancy
Current use of cyclosporin or a TNF blocker
Ocular hypertension IOP >25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation
Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis)
Evidence of acute external ocular infection of the study eye
Active or history of HSV
Previous trauma causing deformity
Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment
Known allergies to product under investigation
Inability to engage in VA testing
Investigator determines that the candidate is not eligible for participation based on clinical or historical factors that would interfere with treatment or impact patient safety not specified above
Current artificial tear use >4x daily
Current use of any topical ocular drops
Anyone who, in the opinion of the investigator, would not be a good candidate for the study.

Intraoperatively

Multiple procedures required
Complication occurs that surgeon determines makes the patient ineligible for study inclusion
Unsuccessful dilation of the punctum to 0.7mm when dilation attempted
during the exam under anesthesia, if it is decided that periocular Kenalog injection is indicated this patient fails screen and will no longer be eligible for the study

Name	Affiliation	Role
Lejla Vajzovic, MD	Duke Eye Center	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Duke Eye Center		Durham	North Carolina	27710	United States

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
FG001	Control Arm (Steroid Drops)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 12, 2022

ID	Title	Description
BG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
BG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00011 BG0014 BG00215

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG0009.27± 2.37 BG00112.25± 2.36 BG00210.06± 2.37

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0007 BG0012 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Region of Enrollment

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00011 BG0014 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Pain as Measured by the FLACC Pain Scale

The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.

Posted

Median

Standard Deviation

score on a scale

Baseline, post-op days 1, 7, 28, and 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG00011 OG0014

Title

Denominators

Categories

Baseline

Title	Measurements
	OG0000± 1.42 OG0010± 0

Post-op day 1

Title	Measurements
	OG000

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Baseline	Wilcoxon (Mann-Whitney)		0.3046														Superiority
OG000 OG001	Post-op day 1	Wilcoxon (Mann-Whitney)

Secondary

Number of Participants With Adverse Events

Adverse events are addressed/ assessed at each visit

Posted

Count of Participants

Participants

Up to post-op day 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Severity of Adverse Events

Adverse events are addressed/ assessed at each visit

Data not collected as no adverse events occurred.

Posted

Up to post-op day 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Ocular Inflammation (AC Cell Count)

Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale, which ranges from 0 to 4. A higher score indicates greater inflammation.

Posted

Median

Standard Deviation

score on a scale

Baseline, post-op days 1, 7, 28, and 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Percentage of Participants With AC (Anterior Chamber) Cell

AC (Anterior Chamber) cell is evaluated during slit lamp and fundus exams during each post-op visit. Resolution defined as AC cell measured at 0 or 0.5 (trace) after surgery.

Posted

Number

percentage of participants

Post-op days 1, 7, 28, and 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Resolution of Pain

This will be measured by using the FLACC Pain Rating Scale. The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale comprised of five behavioral indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10, where a higher score indicates greater pain. Resolution of pain is defined as having a nonzero FLACC score at a postoperative visit and a FLACC score of 0 at a following visit.

Participants with a nonzero FLACC score at a postoperative visit.

Posted

Count of Participants

Participants

up to 45 days post-op

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts

Secondary

Change in Absolute Intraocular Pressure (IOP)

Intraocular pressure is assessed at each visit.

Posted

Median

Inter-Quartile Range

mmHg

Post-op days 1, 7, 28, and 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Number of Participants With Rebound Inflammation

Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams. Rebound inflammation is defined as recurrent AC (Anterior Chamber) cell > 0 or .5 (trace) after initial resolution.

Posted

Count of Participants

Participants

up to 45 days post-op

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops

Supplemental drops needed will be documented at each subsequent visit.

Posted

Count of Participants

Participants

up to 45 days post-op

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Number of Supplemental Drops Needed in Treatment Participants

Supplemental drops needed will be documented at each subsequent visit.

Data not collected as no participants required supplemental drops.

Posted

up to 45 days post-op

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Median Change in Best Corrected Visual Assessment (BCVA) From Baseline

Determined by using either ETDRS (Early Treatment Diabetic Retinopathy Study) or HOTV chart (uses the letters H, O, T, and V) testing depending on age. Visual Acuities were converted to logMAR scores for statistical analyses.

Posted

Median

Inter-Quartile Range

logMAR

baseline, post-op days 1, 7, 28, and 45

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants	OG000

Secondary

Caregivers Treatment Adherence

Documented with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family. Reported on a Likert scale of 1 to 5, with 1 being strongly disagree and 5 being strongly agree to "I sometimes forget to administer my child's eye drops".

Participants who completed the survey.

Posted

Median

Standard Deviation

score on a scale

Day 45 post-op

ID	Title	Description
OG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
OG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Dextenza Arm	Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively	0	11	0	11	0	11
EG001	Control Arm (Steroid Drops)	Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.	0	4	0	4	0	4

ID	Term
D058456	Retinal Telangiectasis
D012167	Retinal Perforations

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases
D013684	Telangiectasis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002123	Calcium Dobesilate
C009935	prednisolone acetate

ID	Term
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds