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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04136366 | The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy | PHASE3 | COMPLETED | 106 | — | — | Nov 15, 2019 | Jun 14, 2022 | Jul 9, 2025 | 23 | United States |
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
| Arm | Type | Description |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | EXPERIMENTAL | ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. |
| Standard surgical care procedure | ACTIVE_COMPARATOR | Standard procedure performed. |
| Name | Type | Description |
|---|---|---|
| ADX-2191 (intravitreal methotrexate 0.8%) | DRUG | ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy |
| Standard surgical care procedure | OTHER | Standard surgical care performed upon completion of pars plana vitrectomy |
Inclusion Criteria: 1. Subject is 18 years or older of any gender or race 2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretinopathy or open globe injury 3. Subject is willing and able to provide written informed consent, comply with cl...