Proliferative Vitreoretinopathy, Retinal Detachment Rhegmatogenous
Conditions
Keywords
topotecan, proliferative vitreoretinopathy, rhegmatogenous retinal detachment
Brief summary
Intravitreal topotecan exhibits strong anti-inflammatory, anti-proliferative, and anti-fibrotic properties, making it a promising option for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment. Preclinical studies have demonstrated its efficacy in proliferative vitreoretinopathy models, where no adverse events have been reported for doses of 5 µg to 30 µg. This prospective, matched cohort study aims to assess the therapeutic efficacy and safety of intravitreal topotecan for preventing and treating proliferative vitreoretinopathy in rhegmatogenous retinal detachment patients.
Detailed description
Patients who provide informed consent for participation in the experimental study arm will undergo standard-of-care retinal detachment surgery with intravitreal topotecan (8 µg/0.05 mL), diluted in sterile saline and administered preoperatively within one week before surgery, as well as one week postoperatively. Matched historical control patients who received standard-of-care retinal detachment surgery without intravitreal topotecan will be eligible for study participation. Both the experimental and historical control study arms will be further divided into two groups: (i) patients with rhegmatogenous retinal detachment who exhibit high-risk characteristics of proliferative vitreoretinopathy on optical coherence tomography or have early proliferative vitreoretinopathy confirmed by clinical examination, and (ii) patients with rhegmatogenous retinal detachment who have neither high-risk characteristics of proliferative vitreoretinopathy nor a history of proliferative vitreoretinopathy.
Interventions
Patients who meet all inclusion criteria and none of the exclusion criteria will receive intravitreal topotecan (8 µg in 0.05 mL). The treatment will be administered within one week before retinal detachment surgery (pneumatic retinopexy, pars plana vitrectomy, and/or scleral buckling) and one week after surgery, for a total of two injections.
PROCEDURERetinal detachment surgery
Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling).
Sponsors
Unity Health Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 years and older 2. Patients who undergo pneumatic retinopexy, pars plana vitrectomy and/or scleral buckling for rhegmatogenous retinal detachment 3. Patients who are voluntarily able and willing to participate Patients undergoing combined phacoemulsification and pars plana vitrectomy and/or scleral buckling will also be included. Any surgical technique will be considered, including relaxing retinotomy or retinectomy during pars plana vitrectomy.
Exclusion criteria
1. Patients with a history of exudative retinal detachment 2. Patients with severe non-proliferative or proliferative diabetic retinopathy 3. Patients with other planned ocular surgery following pars plana vitrectomy 4. Female patients of childbearing age (i.e. less than 50 years old) who intend to become pregnant over the course of the study 5. Patients with pre-existing bone marrow suppression or cytopenias 6. Patients with pre-existing interstitial lung disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of recurrent rhegmatogenous retinal detachment secondary to proliferative vitreoretinopathy | 6 months or last follow-up |
Secondary
| Measure | Time frame |
|---|---|
| Rate of primary retinal reattachment | 6 months or last follow-up |
| Rate of final retinal reattachment | 6 months or last follow-up |
| Grade of proliferative vitreoretinopathy | 6 months or last follow-up |
| Change in best-corrected visual acuity from baseline | 6 months or last follow-up |
| Rate of complications | 6 months or last follow-up |
| Best-corrected visual acuity | 6 months or last follow-up |
Countries
Canada
Contacts
Primary ContactRajeev H Muni, MD MSc FRCSC
Backup ContactMarko M Popovic, MD MPH FRCSC
Outcome results
None listed