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DEXYCU for Inflammation After Childhood Cataract Surgery

This study is looking at the safety of DEXYCU, a single injection given during eye surgery, for treating inflammation after cataract surgery in children. It's being compared to prednisolone acetate ophthalmic eye drops, which are used four times a day for 28 days and then slowly reduced. Children aged 3 years and younger who are having uncomplicated cataract surgery can join. The main goal is to see how much inflammation (measured by anterior chamber cells, or ACC) is present 14 days after surgery. The study plans to enroll 60 participants, but its current status is unclear.

Study design
This is a Phase 3/4, randomized study comparing two treatments. It will involve about 60 participants.
What's involved
Participants will receive either a single injection of Dexamethasone during surgery or use Prednisolone Acetate Ophthalmic eye drops four times a day for 28 days, followed by a tapering schedule.
Compensation
Not stated in the trial record.
Follow-up
Inflammation will be measured 14 days after surgery.

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NCT05191706

Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

Recruiting
PHASE4Up to 3InterventionalTreatment
EyePoint Pharmaceuticals, Inc.
~60 participants
Updated 2025-04-03 on ClinicalTrials.gov
What's tested:DexamethasonePrednisolone Acetate Ophthalmic

At a glance

Recruiting sites
8 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Grade of anterior chamber cells (ACC)
Measured over Post-Operative Day 14

Conditions

Cataract

Explore related trials

Cataract

Where it's being run

9 sites across 6 states
New York3
California2
Massachusetts1
Mississippi1
Nebraska1
South Carolina1

Who to contact

Ramiro Ribeiro, MD, PhD
[email protected]
833-393-7646
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Eligibility criteria

Inclusion

Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
If a contact lens is used for correction of post-operative aphakia, it must be a silicone elastomer lens or a rigid gas permeable lens (no water content).

Exclusion

Presence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, respiratory, or other medical condition that could increase the risk to the subject as determined by the investigator.
Has a post-traumatic cataract.
Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
Ocular hypertension with an IOP in the study eye \>25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.

What this trial measures

  • Grade of anterior chamber cells (ACC)Post-Operative Day 14