Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 1:05 PM
Study NCT ID:
NCT06679634
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2024-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinoblastoma Phase II Expanded Access Clinical Trial
Sponsor:
Targeted Therapy Technologies, LLC
Organization:
Study Overview
Official Title:
Retinoblastoma Phase II Expanded Access Clinical Trial
Status:
RECRUITING
Status Verified Date:
2025-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this research study investigators want to learn more about treatment of advanced or recurrent retinoblastoma. For children with retinoblastoma that have an advanced stage of presentation in one eye or if they have failed all conventional treatment, eye removal is considered. This study will investigate the utility of a chemoplaque(s) to salvage eyes involved with retinoblastoma. The goal of the study is to further determine/assess the safety and efficacy and optimal chemotherapy dose for retinoblastoma.
Detailed Description:
The chemoplaque will be placed during the first exam under anesthesia (EUA) and this involves a surgery wherein the reservoir that will release the chemotherapy medication will be placed under the conjunctiva (surface lining of the eye) and will be applied with tissue adhesive to the sclera (coating of the eye). The chemoplaque will remain on the eye until day 56 when the chemoplaque will be removed. Eye exam under anesthesia (EUAs) will be performed on Day 0, Day 28, Day 56 (prior to chemoplaque removal), and Day 84 (final visit). Blood will be drawn periodically for testing the blood parameters (CBC) and to evaluate toxicity of the medication. Study subjects will be followed until Day 84 when protocol therapy will be completed.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: