VitreoretinopathyEarly Phase 1NCT05620901
DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
A Early Phase 1 study testing Dextenza 0.4Mg Ophthalmic Insert and Pred Forte in people with Vitreoretinopathy and Coats' Disease, run by Lejla Vajzovic, MD, FASRS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitreoretinopathy, Coats' Disease, Exudative Retinopathy
- What is being tested?
- Dextenza 0.4Mg Ophthalmic Insert and Pred Forte
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2023to 24 Feb 2025
- Phase
- Early Phase 1
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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).
- Conditions
- Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome
- Being tested
- Dextenza 0.4Mg Ophthalmic Insert, Pred Forte
- Medical subject headings
- Retinal Telangiectasis, Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextenza 0.4Mg Ophthalmic InsertDrug
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use
Pred ForteDrug
To treat perioperative ocular inflammation and pain;
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively Receives: 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. Receives: Drug: Pred Forte |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, post-op days 1, 7, 28, and 45
Secondary outcomes (11)
Number of Participants With Adverse Events
Adverse events are addressed/ assessed at each visit
Measured: Up to post-op day 45
Severity of Adverse Events
Adverse events are addressed/ assessed at each visit
Measured: Up to post-op day 45
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.
Measured: Baseline, post-op days 1, 7, 28, and 45
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.
Measured: Post-op days 1, 7, 28, and 45
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.
Measured: up to 45 days post-op
Change in Absolute Intraocular Pressure (IOP)
Intraocular pressure is assessed at each visit.
Measured: Post-op days 1, 7, 28, and 45
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.
Measured: up to 45 days post-op
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops
Supplemental drops needed will be documented at each subsequent visit.
Measured: up to 45 days post-op
Number of Supplemental Drops Needed in Treatment Participants
Supplemental drops needed will be documented at each subsequent visit.
Measured: up to 45 days post-op
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.
Measured: baseline, post-op days 1, 7, 28, and 45
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".
Measured: Day 45 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2022
- Study start1 Feb 2023
- Primary completion11 Feb 2025
- Study completion24 Feb 2025
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 VitreoretinopathyStudies 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
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lejla Vajzovic, MD, FASRS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lejla Vajzovic, MD, FASRS, Duke University
- Investigators
- Lejla Vajzovic, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05620901
- Sponsor's protocol ID
- Pro00107533
- Status last verified
- Feb 2026
- First submitted
- 10 Nov 2022
- Last updated
- 23 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05620901
- Acronym / sponsor ID
- Pro00107533
- Conditions
- Vitreoretinopathy, Coats' Disease, Exudative Retinopathy, Lattice Degeneration, Retinal Hole, Sickler's Syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lejla Vajzovic, MD, FASRSUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 17 Nov 2022 (actual)
- Results
- Posted 23 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Dextenza 0.4Mg Ophthalmic InsertDextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively |
| Control Arm | Active comparator | Drug: Pred FortePrednisolone 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. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (17 listed)
- 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:
- Familial Exudative Vitreoretinopathy
- Coats' Disease
- Exudative Retinopathy
- Lattice degeneration
Key exclusion criteria (30 listed)
- 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
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 |
|---|---|---|
| Dextenza 0.4Mg Ophthalmic InsertDEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use | Drug | Treatment Arm |
| Pred ForteTo treat perioperative ocular inflammation and pain; | Drug | Control Arm |
Primary outcome
Pain as Measured by the FLACC Pain Scale
Time frame: Baseline, post-op days 1, 7, 28, and 45
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.
11 secondary outcomes
Number of Participants With Adverse Events
Time frame: Up to post-op day 45
Severity of Adverse Events
Time frame: Up to post-op day 45
Ocular Inflammation (AC Cell Count)
Time frame: Baseline, post-op days 1, 7, 28, and 45
Percentage of Participants With AC (Anterior Chamber) Cell
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Resolution of Pain
Time frame: up to 45 days post-op
Change in Absolute Intraocular Pressure (IOP)
Time frame: Post-op days 1, 7, 28, and 45
Number of Participants With Rebound Inflammation
Time frame: up to 45 days post-op
Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops
Time frame: up to 45 days post-op
Number of Supplemental Drops Needed in Treatment Participants
Time frame: up to 45 days post-op
Median Change in Best Corrected Visual Assessment (BCVA) From Baseline
Time frame: baseline, post-op days 1, 7, 28, and 45
Caregivers Treatment Adherence
Time frame: Day 45 post-op
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- 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.
Lejla Vajzovic, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dextenza 0.4Mg Ophthalmic Insert and Pred Forte in people with Vitreoretinopathy and Coats' Disease, run by Lejla Vajzovic, MD, FASRS at 1 site 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 17 inclusion and 30 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 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2026). 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?
Pain as Measured by the FLACC Pain Scale (time frame: Baseline, post-op days 1, 7, 28, and 45). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Apr 2026.