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DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

Primary Purpose

Vitreoretinopathy, Coats' Disease, Exudative Retinopathy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Dextenza 0.4Mg Ophthalmic Insert
Pred Forte
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreoretinopathy

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Duke Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Treatment Arm

Control Arm

Arm Description

Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively

Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of adverse events
Adverse events are addressed/ assessed at each visit
Severity of Adverse Events
Adverse events are addressed/ assessed at each visit
Degree of 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
Resolution of inflammation or less cell on follow up post op exams
Inflammation is evaluated during slit lamp and fundus exams during each post-op visit
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 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
Ratio of Intraocular pressure increase with insert
Intraocular pressure is assessed at each visit
Percentage of patients with rebound inflammation from baseline through post-op care
Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams
Percentage of patients that were given supplementary prednisolone drops
Supplemental treatment and additional drops needed will be documented at each subsequent visit
The number of drops needed in these patients
Supplemental treatment and additional drops needed will be documented at each subsequent visit
Mean change in Best Corrected Visual Assessment (BCVA)
Determined by using either ETDRS or HOTV chart testing depending on age.
Caregivers Treatment Adherence
Documented at each subsequent visits and with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family.

Full Information

First Posted
November 10, 2022
Last Updated
July 24, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05620901
Brief Title
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
Official Title
The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
Detailed Description
The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/laser to receive either: Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or Control Arm: Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) 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. Each treatment group (surgery or laser) will include 15 patients total, 10 receiving Dextenza and 5 receiving the control drug. Drops for dilation and antibiotic coverage will be used as clinically indicated in all groups throughout the study period. Follow up will occur at post-op day 1, 7, 28/30 and 45 ( +/- three days for all post-operative timepoints).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome, Retinal Detachment Rhegmatogenous, Retinal Detachment Exudative, Retinal Detachment Traction

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/ laser to receive either the Dextenza insert or the Control (Prednisolone Acetate 1%) steroid drops tapered for 28 days post-operatively.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Arm
Arm Type
Experimental
Arm Description
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
Arm Title
Control Arm
Arm Type
Active Comparator
Arm Description
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) 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.
Intervention Type
Drug
Intervention Name(s)
Dextenza 0.4Mg Ophthalmic Insert
Intervention Description
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Intervention Type
Drug
Intervention Name(s)
Pred Forte
Intervention Description
To treat perioperative ocular inflammation and pain;
Primary Outcome Measure Information:
Title
Pain as measured by the FLACC pain scale
Description
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.
Time Frame
up to Day 45 post-op
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
Adverse events are addressed/ assessed at each visit
Time Frame
up to Day 45 post-op
Title
Severity of Adverse Events
Description
Adverse events are addressed/ assessed at each visit
Time Frame
up to Day 45 post-op
Title
Degree of inflammation (AC cell count)
Description
Inflammation is evaluated at each visit during the slit lamp and fundus exam as measured by the ocular inflammation grading scale
Time Frame
up to Day 45 post-op
Title
Resolution of inflammation or less cell on follow up post op exams
Description
Inflammation is evaluated during slit lamp and fundus exams during each post-op visit
Time Frame
up to Day 45 post-op
Title
Resolution of pain
Description
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 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
Time Frame
up to Day 45 post-op
Title
Ratio of Intraocular pressure increase with insert
Description
Intraocular pressure is assessed at each visit
Time Frame
up to Day 45 post-op
Title
Percentage of patients with rebound inflammation from baseline through post-op care
Description
Level of inflammation is evaluated at each post-op visit during slip lamp and fundus exams
Time Frame
up to Day 45 post-op
Title
Percentage of patients that were given supplementary prednisolone drops
Description
Supplemental treatment and additional drops needed will be documented at each subsequent visit
Time Frame
up to Day 45 post-op
Title
The number of drops needed in these patients
Description
Supplemental treatment and additional drops needed will be documented at each subsequent visit
Time Frame
up to Day 45 post-op
Title
Mean change in Best Corrected Visual Assessment (BCVA)
Description
Determined by using either ETDRS or HOTV chart testing depending on age.
Time Frame
up to Day 45 post-op
Title
Caregivers Treatment Adherence
Description
Documented at each subsequent visits and with the primary caregiver satisfaction survey at Day 45. This is a subjective survey for each participants' family.
Time Frame
up to Day 45 post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria Griffiths
Phone
+1 919 660 7416
Email
victoria.griffiths@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lejla Vajzovic, MD
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria Griffiths
Phone
919-660-7416
Email
victoria.griffiths@duke.edu
First Name & Middle Initial & Last Name & Degree
Lejla Vajzovic, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia

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