Table 2 Specification of endpoints
Endpoint | Measurement variable | Analysis metric | Method of aggregation | Time (after initial surgery) |
|---|---|---|---|---|
Primary endpoint: | ||||
PVR grade CP 1 (or higher) | Full thickness retinal fold ≥1 clock hour | - Value (yes/no) | - Proportions | - Within 12 weeks |
Secondary endpoints: | Â | - | - | - |
PVR grade CP 1 (or higher) | Full thickness retinal fold ≥1 clock hour | - Value (yes/no) | - Proportions | - Within 6 weeks |
PVR grade CA 1 (or higher) | Full thickness retinal fold ≥1 clock hour | - Value (yes/no) | - Proportions | - Within 6 weeks and 12 weeks |
Degree of PVR | PVR grade (CA 1–12, and/or CP 1–12) | - Value (yes/no) - Count (clock hours) | - Proportions - Means | - Within 6 weeks and 12 weeks |
Best corrected visual acuity | ETDRS letters | - Count | - Means | - Within 6 weeks and 12 weeks |
Retinal re-attachment after primary intervention | Retinal attachment in all 4 quadrants | - Value (yes/no) | - Proportions | - Within 6 weeks and 12 weeks |
Number of retinal re-detachments | Number of retinal re-detachments if present, re-detachments due to PVR | - Count (>0) - Value (yes/no) | - Proportions | - Within 6 weeks and 12 weeks |
Number and extent of surgical procedures to achieve retinal attachment | Number of procedures number of intraoperative procedures number of serious/ complex procedures | - Count (>0) - Value (yes/no) | - Proportions | - Within 12 weeks |
Occurrence of at least one drug-related adverse event that affects the study eye | Drug-related adverse event that affects the study eye | - Count | - Proportions | - Within 12 weeks |