Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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