Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

Rhegmatogenous retinal detachment (RRD) is an acute, sight-threatening condition that occurs after separation of the neurosensory retina from the underlying retinal pigment epithelium (RPE) due to the presence of a retinal break. Proliferative vitreoretinopathy (PVR) represents growth of ectopic fibrocellular growth on the surface of, within and underneath the retina. PVR is hypothesized to occur secondary to the migration of RPE cells to the peri-retina, leading to a mesenchymal transition into contractile myofibroblasts. PVR affects 5-10% of RRDs and is the most common cause of surgical failure in RRD. Given that PVR involves a pro-inflammatory and pro-fibrotic cellular response, adjuvants such as corticosteroids and antimetabolites such as 5-fluorouracil have been attempted in the treatment of this condition. Overall, the efficacy results of these treatments have been mixed, and no standard of care adjuvant therapy has emerged. Topotecan is a chemotherapeutic agent that acts as a topoisomerase inhibitor. It is most commonly administered intravitreally for patients with refractory or recurrent vitreous seeds from retinoblastoma, and shows high efficacy in this setting. At the same time, intravitreal topotecan administered at doses of 5-30µg has been associated with no ocular or systemic complications or adverse electroretinogram changes. To the best of available knowledge, topotecan has not been administered for the treatment of proliferative vitreoretinopathy. Topotecan has anti-inflammatory, anti-proliferative and anti-fibrotic activity that is hypothesized to exhibit high efficacy for the treatment of PVR. In this study, the efficacy and safety of intravitreal topotecan for the treatment of PVR will be investigated. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06425419
Study type Interventional
Source Massachusetts Eye and Ear Infirmary
Contact Leo Kim, MD, PhD
Phone 617-391-5896
Email leo_kim@meei.harvard.edu
Status Not yet recruiting
Phase Phase 1
Start date July 1, 2024
Completion date March 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT04403750 - Combined Laser-surgical Technology of RRD Treatment N/A
Not yet recruiting NCT04520789 - Early Prevention Strategies of Severe Proliferative Vitreoretinopathy Base on Precision Diagnosis of Single Cell Sequencingvitreoretinopathy N/A
Recruiting NCT04571788 - Treating Rhegmatogenous Retinal Detachment by Foldable Capsular Buckle
Completed NCT02834559 - Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment. Phase 3
Recruiting NCT01845571 - Retinal Detachment - Demographic and Clinical Survey
Completed NCT04891991 - Intravitreal Infliximab for Proliferative Vitreoretinopathy Phase 2
Recruiting NCT02871531 - Pneumatic Retinopexy Versus Vitrectomy for Retinal Detachment in Patients With Extended Criteria N/A
Completed NCT00757536 - Primary Vitrectomy With Endolaser or Encircling Band for Rhegmatogenous Retinal Detachment N/A
Active, not recruiting NCT00370201 - Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment Phase 3
Completed NCT00345007 - Macular Function After Scleral Buckle N/A
Recruiting NCT05331664 - Dropless Pars Plana Vitrectomy Study Phase 4
Completed NCT02841306 - Ursodeoxycholic Acid for Rhegmatogenous Retinal Detachment Phase 1
Not yet recruiting NCT02185469 - Corneal Endothelial Cell Loss After Pneumatic Retinopexy for the Repair of Primary Rhegmatogenous Retinal Detachment N/A
Not yet recruiting NCT01647373 - Axial Length Change in Eyes Treated by Silicone Sponge Scleral Buckling N/A
Completed NCT01068379 - Clinical Trial of Cryotherapy Versus Postoperative Laser Photocoagulation Phase 3
Not yet recruiting NCT06468397 - Acute Retinal Detachment Repair With the iSeelr^TM Retinal Detachment Repair System N/A
Recruiting NCT06056596 - Lamivudine and Plasma Markers of Inflammation in Retinal Detachment Early Phase 1
Completed NCT01343134 - Anatomical and Functional Macular Changes in Retinal Detachment N/A
Recruiting NCT05588037 - Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery N/A
Completed NCT03542162 - Healaflow Patch for the Treatment of Rhegmatogenous Retinal Detachment N/A