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Intravitreal Topotecan for Proliferative Vitreoretinopathy

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Study Aim

This study aims to evaluate the safety and effects of intravitreal Topotecan on preventing retinal detachment recurrence in patients with proliferative vitreoretinopathy.

What is being tested

Topotecan

Drug
Who is being recruted

Eye Diseases

+ Retinal Diseases

+ Vitreoretinopathy, Proliferative

Over 18 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2026
See protocol details

Summary

Principal SponsorMassachusetts Eye and Ear Infirmary
Study ContactLeo Kim, MD, PhD
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

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.

Official TitleThe Safety and Efficacy of Intravitreal Topotecan for the Treatment of Proliferative Vitreoretinopathy 
NCT06425419
Principal SponsorMassachusetts Eye and Ear Infirmary
Study ContactLeo Kim, MD, PhD
Last updated: December 13, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

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

Eye DiseasesRetinal DiseasesVitreoretinopathy, Proliferative

Criteria

3 inclusion criteria required to participate
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.

13 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
These are the patients who will be receiving intravitreally 20 micrograms of topotecan in a 1cc syringe during surgery, at the post-operative day 7 and at the post-operative day 28.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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