The Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy

Launched by MASSACHUSETTS EYE AND EAR INFIRMARY · May 20, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for a serious eye condition called proliferative vitreoretinopathy (PVR), which can lead to retinal detachment. The researchers want to find out if a medication called intravitreal topotecan, given during and after surgery, is safe and effective for patients with this condition. Participants will undergo a standard surgery to fix the retinal detachment and, if chosen to receive the medication, will get it at different times after the surgery. The goal is to see how well the treatment works compared to those who do not receive it, particularly looking at whether the retinal detachment comes back or if the retina stays attached.

To be eligible for this trial, participants need to be over 18 years old and have a retinal detachment due to PVR or from an eye injury. They must also be undergoing a specific type of surgery known as vitrectomy. Throughout the trial, participants will have several follow-up visits to check their eye health and monitor for any side effects. It’s important to note that individuals who are pregnant, have certain other eye conditions, or cannot commit to follow-up visits may not be able to participate. This trial is not yet recruiting, so there will be more information to come as it gets underway.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients \> 18 years old
• • Patients presenting with retinal detachment due with PVR (grade C or higher) or retinal detachment associated with open globe trauma
• • Patients undergoing vitrectomy or vitrectomy with scleral buckle as part of standard care.
• Exclusion Criteria:
• • Patient unable to give consent
• • Patient unable to follow-up
• • Females of childbearing age who are pregnant at the time of recruitment. A pregnancy test will be done to all women of ages 18-55 prior to surgery to ensure they are not pregnant at the time of recruitment.
• • Patients with a history of tractional or exudative retinal detachment.
• • Patients with other planned ocular surgery following PPV
• • Active or chronic or recurrent uncontrolled ocular or systemic disease
• • Active or history of chronic or recurrent inflammatory eye disease
• • Diagnosis of severe nonproliferative or proliferative diabetic retinopathy or vasoproliferative disease in the operative eye
• • Signs of ocular infection at presentation in either eye
• • Known or suspected sensitivity or allergy to any of the medications used in the operation or postoperatively
• • No Light Perception vision in the operative eye
• • Failure to achieve intraoperative reattachment
• • Patient with silicone oil instilled in the operative eye at time of presentation