Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06818721 | Intravitreal Topotecan for Prevention or Treatment of Proliferative Vitreoretinopathy in Retinal Detachment | PHASE2 | NOT YET_RECRUITING | 394 | — | — | Mar 1, 2025 | Apr 1, 2027 | Mar 6, 2025 | 2 | Canada |
| Arm | Type | Description |
|---|---|---|
| Intravitreal topotecan with retinal detachment surgery | EXPERIMENTAL | Intravitreal topotecan 8 µg/0.05mL, diluted in sterile saline and administered preoperatively, within one week prior to surgery, as well as one week postoperatively. |
| Retinal detachment surgery | ACTIVE_COMPARATOR | Historical control patients who previously received standard of care surgery for rhegmatogenous retinal detachment without intravitreal topotecan. |
| Name | Type | Description |
|---|---|---|
| Intravitreal topotecan | DRUG | 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. |
| Retinal detachment surgery | PROCEDURE | Standard retinal detachment surgery (pneumatic retinopexy, three-port pars plana vitrectomy, and/or scleral buckling). |
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...