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

Starting soon · Phase 1

Conditions studied: Proliferative Vitreoretinopathy, Proliferative Vitreo-Retinopathy, Rhegmatogenous Retinal Detachment

In brief

The goal of this clinical trial is to evaluate the safety and efficacy of intravitreal topotecan for the treatment of patients with rhegmatogenous retinal detachment due to proliferative vitreoretinopathy (PVR) or resulting from an open globe injury, and compare the outcomes to those who do no receive intravitreal topotecan. The main objectives it aims to achieve are: * to study the safety profile of intravitreal topotecan in the treatment of PVR * to evaluate the efficacy of intravitreal topotecan in treating PVR. Post-consent, participants will: * undergo vitrectomy (with or without scleral buckle) as part of standard treatment for retinal detachment. * receive intravitreal topotecan at the time of surgery, post-operative day 7 and post-operative day 28 (if randomized to receive the medication) * come in at post-operative day 1, 7, 28, 56, 84, 126 and 168 to undergo a complete ophthalmic exam along with a fundus photography and optical coherence tomography of the macula, have their intraocular pressure and visual acuity measured and their adverse events monitored, if any. Researchers will compare participants who receive intravitreal topotecan for PVR to those who do not to see if there is a significant variability in recurrence of retinal detachment, rate of retinal reattachment and PVR grade 6 months after surgery.

Key facts

Study ID

NCT06425419

Run by

Massachusetts Eye and Ear Infirmary

People needed

50

Starts

2026-09-01

Expected to finish

2028-09-01

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Full record on ClinicalTrials.gov

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