Actively Recruiting

Phase 4
Age: 0 - 3Years
All Genders
NCT05191706

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

Led by EyePoint Pharmaceuticals, Inc. · Updated on 2025-04-03

60

Participants Needed

9

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCUfor the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 3Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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).
  • Other protocol-specified inclusion criteria may apply.
Not Eligible

You will not qualify if you...

  • 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.
  • Other protocol-specified exclusion criteria may apply.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

EyePoint Investigational Site

Huntington Beach, California, United States, 92647

Actively Recruiting

2

EyePoint Investigational Site

Palo Alto, California, United States, 94303

Active, Not Recruiting

3

EyePoint Investigative Site

Boston, Massachusetts, United States, 02118

Actively Recruiting

4

EyePoint Investigational Site

Jackson, Mississippi, United States, 39216

Actively Recruiting

5

EyePoint Investigational Site

Omaha, Nebraska, United States, 68114

Actively Recruiting

6

EyePoint Investigational Site

Buffalo, New York, United States, 14209

Actively Recruiting

7

EyePoint Investigative Site

New York, New York, United States, 10032

Actively Recruiting

8

EyePoint Investigational Site

Rochester, New York, United States, 14642

Actively Recruiting

9

EyePoint Investigational Site

Charleston, South Carolina, United States, 29425

Actively Recruiting

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Research Team

R

Ramiro Ribeiro, MD, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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