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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 post-operative day 14
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 weeks
Treatment ~ Varies
Follow Up ~post-operative day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Grade of anterior chamber cells (ACC)
Secondary outcome measures
Grade of anterior chamber flare (ACF)

Side effects data

From 2013 Phase 4 trial • 122 Patients • NCT01474915
2%
Deep Vein Thrombosis
2%
Cerebrospinal fluid leak
2%
Fever
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ondansetron
Aprepitant

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
16 Previous Clinical Trials
1,871 Total Patients Enrolled
4 Trials studying Cataract
727 Patients Enrolled for Cataract

Media Library

Dexamethasone (Corticosteroid) Clinical Trial Eligibility Overview. Trial Name: NCT05191706 — Phase 4
Cataract Research Study Groups: DEXYCU (dexamethasoneintraocular suspension) 9%, Prednisolone acetate ophthalmic suspension (USP) 1%
Cataract Clinical Trial 2023: Dexamethasone Highlights & Side Effects. Trial Name: NCT05191706 — Phase 4
Dexamethasone (Corticosteroid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05191706 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Dexamethasone been granted authorization by the US Food and Drug Administration?

"There is significant evidence backing the safety of Dexamethasone, so it has attained a score of 3."

Answered by AI

What is the estimated participant count for this research endeavor?

"Affirmative, the clinicaltrials.gov database states that this research effort is actively searching for participants. As of July 25th 2022, the trial was initially posted on April 1st and has been updated since then. Sixty individuals must be recruited across 2 medical centres to meet the criteria established by this study."

Answered by AI

Are researchers still accepting participants for this experiment?

"Affirmative. The information on clinicaltrials.gov suggests that this research is currently seeking participants, having been first posted on April 1st 2022 and recently updated on July 25th 2022. 60 patients must be recruited from two separate medical sites."

Answered by AI

What ailments does Dexamethasone typically address?

"Dexamethasone is a popular medication for both ophthalmic and sympathetic conditions. It can be of particular use in the treatment of branch retinal vein occlusion, macular edema, as well as certain bacterial eye infections."

Answered by AI

Are there any past investigations involving Dexamethasone?

"To date, 555 research projects concerning dexamethasone are active. Of those clinical trials, 144 have reached Phase 3 and are based in Mishawaka, Indiana. However, across the planet 18657 sites are conducting inquiries into this medication's efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
EyePoint Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract
2022. "Evaluate the Safety of DEXYCU for the Treatment of Inflammation Following Ocular Surgery for Childhood Cataract". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05191706.
All > Cataract
~14 spots leftby Jan 2025
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