DEXTENZA in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia
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)
Sponsor: Lejla Vajzovic, MD, FASRS
Listed as NCT05620901, this observational or N/A phase trial focuses on Coats' Disease and Exudative Retinopathy and remains completed. Sponsored by Lejla Vajzovic, MD, FASRS, it has been updated 8 times since 2023, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)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:
1. Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or
2. 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).
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:
1. Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or 2. 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).
Status Flow
Change History
8 versions recorded-
Apr 28, 2026 — Present [daily]
Completed
Phase: EARLY_PHASE1 → None
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Sep 2025 — Apr 2026 [monthly]
Completed EARLY_PHASE1
Status: Recruiting → Completed
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Feb 2025 — Sep 2025 [monthly]
Recruiting EARLY_PHASE1
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Sep 2024 — Feb 2025 [monthly]
Recruiting EARLY_PHASE1
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Jul 2024 — Sep 2024 [monthly]
Recruiting EARLY_PHASE1
▶ Show 3 earlier versions
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Aug 2023 — Jul 2024 [monthly]
Recruiting EARLY_PHASE1
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Apr 2023 — Aug 2023 [monthly]
Recruiting EARLY_PHASE1
Status: Not Yet Recruiting → Recruiting
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Dec 2022 — Apr 2023 [monthly]
Not Yet Recruiting EARLY_PHASE1
First recorded
Eligibility 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.
Contact Information
- Lejla Vajzovic, MD, FASRS
For direct contact, visit the study record on ClinicalTrials.gov .