Intravitreal Topotecan for Proliferative Vitreoretinopathy
This study aims to evaluate the safety and effects of intravitreal Topotecan on preventing retinal detachment recurrence in patients with proliferative vitreoretinopathy.
Topotecan
Eye Diseases
+ Retinal Diseases
+ Vitreoretinopathy, Proliferative
Treatment Study
Summary
Study start date: April 1, 2026
Actual date on which the first participant was enrolled.This study focuses on testing a new way to treat a condition called Proliferative Vitreoretinopathy (PVR), which can happen after a specific kind of retinal detachment known as rhegmatogenous retinal detachment (RRD). In PVR, unwanted cell growth occurs on and around the retina, which can lead to surgical failures when trying to fix the retinal detachment. Current treatments for PVR, like corticosteroids and 5-fluorouracil, do not work consistently well, so there is no standard treatment. The study is exploring the use of a drug called Topotecan, which has shown potential in treating similar eye conditions, to see if it can effectively and safely manage PVR. Participants in the study will receive Topotecan directly into the eye through an injection, a method known as intravitreal injection. This approach has been previously used for other eye conditions without causing major side effects. Researchers will carefully monitor the participants to evaluate the drug's effectiveness in reducing the unwanted cell growth associated with PVR and to ensure it does not cause any harm. The study aims to gather data on both the safety and potential benefits of using Topotecan to treat PVR, which could help in developing a more reliable treatment option for those affected by this condition.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.50 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives