Evaluating DEXYCU for treating inflammation after childhood cataract surgery
A Phase 3/4, Prospective, Randomized, Active Treatment-Controlled, Parallel-Design, Multicenter Study to Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
This study is testing if a new eye treatment called DEXYCU can help reduce inflammation after cataract surgery in children.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | N/A to 3 Years |
| Sex | All |
| Sponsor | EyePoint Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 9 sites (Huntington Beach, California and 8 other locations) |
| Trial ID | NCT05191706 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the safety of DEXYCU, a dexamethasone formulation, in treating inflammation that occurs following ocular surgery for childhood cataracts. It is a Phase 4, multicenter, randomized, active treatment-controlled study involving pediatric patients undergoing uncomplicated cataract surgery. Participants will receive either DEXYCU or a standard treatment, and their outcomes will be monitored to assess safety and efficacy. The study is designed to provide insights into the optimal management of post-operative inflammation in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are children undergoing uncomplicated cataract surgery with or without intraocular lens implantation.
Not a fit: Patients with post-traumatic cataracts or significant comorbidities that could increase surgical risks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of inflammation in children after cataract surgery, enhancing recovery and visual outcomes.
How similar studies have performed: Other studies have shown promise in using corticosteroids for post-operative inflammation, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where this trial is running
Huntington Beach, California and 8 other locations
- EyePoint Investigational Site — Huntington Beach, California, United States (Recruiting)
- EyePoint Investigational Site — Palo Alto, California, United States (Active_not_recruiting)
- EyePoint Investigative Site — Boston, Massachusetts, United States (Recruiting)
- EyePoint Investigational Site — Jackson, Mississippi, United States (Recruiting)
- EyePoint Investigational Site — Omaha, Nebraska, United States (Recruiting)
- EyePoint Investigational Site — Buffalo, New York, United States (Recruiting)
- EyePoint Investigative Site — New York, New York, United States (Recruiting)
- EyePoint Investigational Site — Rochester, New York, United States (Recruiting)
- EyePoint Investigational Site — Charleston, South Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Ramiro Ribeiro, MD, PhD
- Email: rribeiro@eyepointpharma.com
- Phone: 833-393-7646
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.