RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-01-04
Study Completion:2025-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05191706

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 3 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Undergoing uncomplicated cataract surgery with or without a posterior chamber intraocular lens (IOL) implantation.
  2. * 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).
  3. * Other protocol-specified inclusion criteria may apply.
  1. * 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.
  2. * Has a post-traumatic cataract.
  3. * Presence of active or suspected viral, bacterial, or fungal disease in the study eye.
  4. * Ocular hypertension with an IOP in the study eye \>25 mmHg at Screening with or without treatment with anti-glaucoma monotherapy.
  5. * Subjects who have received a periocular corticosteroid injection in the study eye in the 3 months prior to Screening.
  6. * Subjects who have received any intravitreal corticosteroid delivery vehicle (eg, Retisert®, Ozurdex®, Iluvien®) in the study eye at any time.
  7. * Other protocol-specified exclusion criteria may apply

Contacts and Locations

Study Contact

Ramiro Ribeiro, MD, PhD
CONTACT
833-393-7646
rribeiro@eyepointpharma.com

Study Locations (Sites)

EyePoint Investigational Site
Huntington Beach, California, 92647
United States
EyePoint Investigational Site
Palo Alto, California, 94303
United States
EyePoint Investigative Site
Boston, Massachusetts, 02118
United States
EyePoint Investigational Site
Jackson, Mississippi, 39216
United States
EyePoint Investigational Site
Omaha, Nebraska, 68114
United States
EyePoint Investigational Site
Buffalo, New York, 14209
United States
EyePoint Investigative Site
New York, New York, 10032
United States
EyePoint Investigational Site
Rochester, New York, 14642
United States
EyePoint Investigational Site
Charleston, South Carolina, 29425
United States

Collaborators and Investigators

Sponsor: EyePoint Pharmaceuticals, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-01-04
Study Completion Date2025-02

Study Record Updates

Study Start Date2022-01-04
Study Completion Date2025-02

Terms related to this study

Keywords Provided by Researchers

  • pediatric
  • cataract

Additional Relevant MeSH Terms

  • Cataract