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.
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.
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.
Parallel
Topotecan
Drug20 micrograms of intravitreal topotecan given in a 1 cc tuberculin syringe at a concentration of 20 mcg/20mcL.
Recurrence of rhegmatogenous retinal detachment secondary to PVR
Investigators will be evaluating whether participant develop a recurrent retinal detachment throughout their follow up after their initial surgery.
Best corrected visual acuity (BCVA)
Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up
Variation of PVR grade
Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the grade of the PVR changes over time. PVR grade goes from grade A to grade C-Anterior to equator/ C-Posterior to equator (grade C being worse than grade A)
Retinal reattachment rate at month 6 or last follow up
Investigators will be doing a dilated fundus exam and taking fundus photographies for all participants throughout their follow up time to see if the retinal reattaches (whether completely or partially) after surgery
Recurrence of rhegmatogenous retinal detachment due to any cause
Investigators will be measuring the BCVA of participants throughout their follow up and see if they notice any change from surgery time to final follow up
Optical coherence tomography (OCT) of the macula
an OCT of the macula will be taken to evaluate for any retinal changes throughout the study
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Massachusetts Eye and Ear Infirmary
Lead sponsor
Massachusetts General Hospital
Sponsor institution
This trial is not recruiting at the moment. You can still explore other options:
