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Corticosteroid
DEXYCU for Post-Surgical Inflammation in Childhood Cataract
Phase 4
Recruiting
Research Sponsored by EyePoint Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 60 Other Conditions
Pivotal Trial
Summary
This trial is testing whether the medication DEXYCU is safe for treating inflammation following ocular surgery for childhood cataract.
Who is the study for?
This trial is for children undergoing routine cataract surgery, with or without lens implantation. Participants must not have post-traumatic cataracts, eye infections, high eye pressure over 25 mmHg even with treatment, or recent corticosteroid injections in the eye. They should also be free of major health issues that could increase risks.
What is being tested?
The study compares DEXYCU (a dexamethasone-based drug) to Prednisolone Acetate Ophthalmic to see which is safer for reducing inflammation after a child's cataract surgery. It's a controlled test where patients are randomly assigned to one of the treatments.
What are the potential side effects?
Possible side effects include increased eye pressure, pain at the injection site inside the eye, and potential risk of infection. There may also be blurred vision and other less common reactions related to steroid use in eyes.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2013 Phase 4 trial • 122 Patients • NCT014749152%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 60 Other Conditions
This treatment demonstrated efficacy for 60 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DEXYCU (dexamethasoneintraocular suspension) 9%Experimental Treatment1 Intervention
A single 0.005-mL anterior chamber injection of DEXYCU (dexamethasoneintraocular suspension) 9%, equivalent to 517mcg dexamethasone.
Group II: Prednisolone acetate ophthalmic suspension (USP) 1%Active Control1 Intervention
Active treatment control, prednisolone acetate ophthalmic suspension (USP) 1%, four times daily (QID) for 28days, followed by a treatment taper at the investigator's discretion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dexamethasone
FDA approved
Find a Location
Who is running the clinical trial?
EyePoint Pharmaceuticals, Inc.Lead Sponsor
18 Previous Clinical Trials
2,643 Total Patients Enrolled
4 Trials studying Cataract
727 Patients Enrolled for Cataract
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye pressure is over 25 mmHg, even with treatment.I have a cataract caused by an injury.I do not have any major health issues that could make the trial unsafe for me.I have not had a corticosteroid injection near my eye in the last 3 months.I have received a corticosteroid implant in my eye.I suspect or have been diagnosed with an eye infection.I am having a straightforward cataract surgery, with or without lens implant.My contact lens for after cataract surgery is silicone or rigid gas permeable.
Research Study Groups:
This trial has the following groups:- Group 1: DEXYCU (dexamethasoneintraocular suspension) 9%
- Group 2: Prednisolone acetate ophthalmic suspension (USP) 1%
Awards:
This trial has 5 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 60 Other Conditions - This treatment demonstrated efficacy for 60 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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