Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00327444 | Ovarian Neoplasms | Time to Repeat Paracentesis (TRP) From Day 1 up to 6 months from randomization | Aflibercept | 55.1 days (±7.25 Standard Error) |
| Placebo | 23.3 days (±7.70 Standard Error) | |||
| NCT00509795 VIEW1 | Macular Degeneration | Percentage of Patients Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) Baseline and at week 52 | IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 95.9 percentage of patients |
| IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4 | 95.1 percentage of patients | |||
| IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8 | 95.1 percentage of patients | |||
| Ranibizumab 0.5mg Q4 | 94.4 percentage of patients | |||
| Total | 95.1 percentage of patients | |||
| NCT00519285 VENICE | Neoplasm Metastasis | Overall Survival Time From randomization up to the cut-off date (median follow-up of 35.4 months) | Aflibercept | 22.14 months |
| Placebo | 21.22 months | |||
| NCT00532155 VITAL | Lung Neoplasms | Overall Survival (OS) Baseline to the date when 687 deaths occurred (26 January 2011) | Aflibercept/Docetaxel | 10.05 months |
| Placebo/Docetaxel | 10.41 months | |||
| NCT00561470 VELOUR | Colorectal Neoplasms | Overall Survival (OS) From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years) | Aflibercept/FOLFIRI | 13.50 months |
| Placebo/FOLFIRI | 12.06 months | |||
| NCT00574275 VANILLA | Pancreatic Neoplasms | Overall Survival (OS) From the first randomization until the end of study data cutoff date (approximately 2 years) | Aflibercept and Gemcitabine | 6.54 months |
| Placebo and Gemcitabine | 7.75 months | |||
| NCT00637377 VIEW 2 | Macular Degeneration | Percentage of Participants Who Maintained Vision at Week 52 - Last Observation Carried Forward (LOCF) At week 52 | Aflibercept Injection (EYLEA, VEGF Trap-Eye) 0.5mg Q4 | 96.27 Percentage of participants |
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q4 | 95.62 Percentage of participants | |||
| Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg Q8 | 95.56 Percentage of participants | |||
| Ranibizumab 0.5mg Q4 | 94.42 Percentage of participants | |||
| NCT00964795 | Macular Degeneration | Safety and Tolerability of Intravitreal Aflibercept Injection in Participants With Neovascular AMD Baseline (day 1) through end of treatment (Week 180) | Open-label Intravitreal Aflibercept Injection | 239 participants |
| Open-label Intravitreal Aflibercept Injection | 204 participants | |||
| Open-label Intravitreal Aflibercept Injection | 290 participants | |||
| Open-label Intravitreal Aflibercept Injection | 17 participants | |||
| Open-label Intravitreal Aflibercept Injection | 12 participants | |||
| Open-label Intravitreal Aflibercept Injection | 105 participants | |||
| Open-label Intravitreal Aflibercept Injection | 232 participants | |||
| Open-label Intravitreal Aflibercept Injection | 169 participants | |||
| NCT01012973 GALILEO | Macular Edema | Percentage of Participants Who Gained at Least 15 Letters in BCVA as Measured by ETDRS Letter Score Compared With Baseline at Week 24 With Discontinued Participants Before Week 24 Evaluated as Failures Baseline and Week 24 | Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) | 60.2 Percentage of participants |
| Sham Treatment | 22.1 Percentage of participants | |||
| NCT01363440 VISTA DME | Diabetic Retinopathy | Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) Baseline and Week 52 | Control | .10 letters correctly read (±1.03 Standard Error) |
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4 | 12.3 letters correctly read (±.76 Standard Error) | |||
| Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8 | 10.6 letters correctly read (±.69 Standard Error) | |||
| NCT01482910 | Macular Degeneration | Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by ETDRS Letter Score at Week 28 - Last Observation Carried Forward (LOCF) Baseline and at week 28 | Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321) | 14.0 Letters correctly read (±12.1 Standard Deviation) |
| PDT Treatments | 3.9 Letters correctly read (±14.6 Standard Deviation) | |||
| NCT01521559 VIBRANT | Retinal Vein Occlusion | Participants Who Gained at Least 15 Letters in Best Corrected Visual Acuity (BCVA) at Week 24 - LOCF Baseline to week 24 | Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) | 48 participants |
| Macular Laser Photocoagulation Treatment (Control) | 24 participants | |||
| NCT01571284 | — | Creatinine Clearance of Aflibercept Plus FOLFIRI Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 71.4 mL/min (±29.3 Standard Deviation) |
| NCT01571284 | — | Number of Participants With Abnormal Electrolytes Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 52 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 32 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 213 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 5 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 166 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 16 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 121 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 10 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 75 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 181 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 1 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 2 Participants | |||
| NCT01571284 | — | Number of Participants With Abnormal Hematological Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 532 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 72 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 450 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 13 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 293 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 14 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 535 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 227 Participants | |||
| NCT01571284 | — | Number of Participants With Abnormal Non-Gradable Biochemistry Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 83 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 60 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 250 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 77 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 79 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 423 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 135 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 41 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 162 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 217 Participants | |||
| NCT01571284 | — | Number of Participants With Abnormal Renal and Liver Function Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 465 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 342 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 9 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 10 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 130 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 2 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 270 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 161 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 12 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 23 Participants | |||
| NCT01571284 | — | Number of Participants With Cycle Delay and/or Dose Modification Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 97 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 43 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 5 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 308 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 39 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 163 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 660 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 119 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 5 Participants | |||
| NCT01571284 | — | Number of Participants With International Normalized Ratio (INR) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 2 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 106 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 0 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 2 Participants | |||
| NCT01571284 | — | Number of Participants With Other Abnormal Biochemistry Parameters Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 90 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 6 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 6 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 241 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 30 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 403 Participants | |||
| NCT01571284 | — | Number of Participants With Proteinuria (Grade>=2) Concomitant With Hematuria and /or Hypertension Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 72 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 3 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 4 Participants | |||
| NCT01571284 | — | Number of Participants With Proteinuria Events Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 286 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 5 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 123 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 54 Participants | |||
| NCT01571284 | — | Number of Participants With Proteinuria Grade >=2 Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 182 participants |
| NCT01571284 | — | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 272 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 104 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 208 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 47 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 159 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 609 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 769 Participants | |||
| NCT01571284 | — | Number of Participants With Urinary Protein-Creatinine Ratio (UPCR) Baseline up to 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure: 214 weeks) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 265 Participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 27 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 24 Participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 51 Participants | |||
| NCT01627249 Protocol T | — | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score <69 Baseline to 1-year | Aflibercept | 18.9 units on a scale (±11.5 Standard Deviation) |
| Bevacizumab | 11.8 units on a scale (±12.0 Standard Deviation) | |||
| Ranibizumab | 14.2 units on a scale (±10.6 Standard Deviation) | |||
| NCT01627249 Protocol T | — | Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year: Baseline Visual Acuity Letter Score 78-69 Baseline to 1-year | Aflibercept | 8.0 units on a scale (±7.6 Standard Deviation) |
| Bevacizumab | 7.5 units on a scale (±7.4 Standard Deviation) | |||
| Ranibizumab | 8.3 units on a scale (±6.8 Standard Deviation) | |||
| NCT01627249 Protocol T | — | Overall Change in Electronic Early Treatment Diabetic Retinopathy Study Visual Acuity Letter Score From Baseline to 1-year Baseline to 1-year | Aflibercept | 13.3 units on a scale (±11.1 Standard Deviation) |
| Bevacizumab | 9.7 units on a scale (±10.1 Standard Deviation) | |||
| Ranibizumab | 11.2 units on a scale (±9.4 Standard Deviation) | |||
| NCT01661270 AFLAME | — | Progression-free Survival (PFS) 26.7 months | Aflibercept | 6.93 months |
| Placebo | 5.59 months | |||
| NCT01670721 AFEQT | — | Percentage of Participants With Adverse Events (AEs) Baseline upto 30 days after the last treatment administration (either Aflibercept or FOLFIRI whichever comes last) (maximum exposure:723 days) | Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 100.00 Percentage of participants |
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 21.1 Percentage of participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 16.0 Percentage of participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 23.4 Percentage of participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 9.1 Percentage of participants | |||
| Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin) | 40.6 Percentage of participants | |||
| NCT01783886 VIVID EAST | Macular Edema | Change From Baseline in Best Corrected Visual Acuity (BCVA) as Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score at Week 52 - Last Observation Carried Forward (LOCF) Baseline up to week 52 | Intravitreal Aflibercept Injection 2Q4 | 13.7 Letters correctly read (±8.4 Standard Deviation) |
| Intravitreal Aflibercept Injection 2Q8 | 12.8 Letters correctly read (±9.5 Standard Deviation) | |||
| Macular Laser Photocoagulation | -0.2 Letters correctly read (±13.5 Standard Deviation) | |||
| NCT01909791 Protocol V | — | Number of Eyes With at Least 5-letter Decrease in E-ETDRS Visual Acuity Letter Score From Baseline 2 years | Initiation With Aflibercept | 33 Eyes |
| Initiation With Laser Photocoagulation | 36 Eyes | |||
| Initiation With Observation | 39 Eyes | |||
| NCT01940887 | Macular Degeneration | Mean Change in Visual Acuity (Measured at Baseline and at the Month 12 Visit) 12 months | E10030 + Bevacizumab or Aflibercept | 9.42 letters (±0.85 Standard Error) |
| Sham + Bevacizumab or Aflibercept | 9.04 letters (±0.85 Standard Error) | |||
| NCT01969708 SCORE2 | Retinal Vein Occlusion | Mean Change From Baseline in Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity Letter Score at Month 6 Month 0 to 6 | Aflibercept | 18.9 letters read |
| Bevacizumab | 18.6 letters read | |||
| NCT02307682 HAWK | Choroidal Neovascularization | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye Baseline, Week 48 | Aflibercept 2 mg | 7.0 letters (±13.16 Standard Deviation) |
| Brolucizumab 3 mg | 5.9 letters (±13.49 Standard Deviation) | |||
| Brolucizumab 6 mg | 6.4 letters (±14.40 Standard Deviation) | |||
| NCT02396316 VEGA | Glaucoma, Neovascular | Change in Intraocular Pressure (IOP) From Baseline to Pre-dose at Week 1 From baseline to pre-dose at Week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | -8.5 mmHg (±8.7 Standard Deviation) |
| Sham Injection Group | -4.9 mmHg (±10.8 Standard Deviation) | |||
| NCT02434328 HARRIER | Choroidal Neovascularization | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Letters Read) at Week 48 - Study Eye Baseline, Week 48 | Aflibercept 2 mg | 7.6 letters (±12.47 Standard Deviation) |
| Brolucizumab 6 mg | 6.9 letters (±11.47 Standard Deviation) | |||
| NCT02540954 | Macular Degeneration | Mean Change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letter Score for the Study Eye From baseline to Week 52 | Aflibercept 2Q8 (2 mg Aflibercept Administered Every 8 Weeks) | -0.5 Letters read correctly (±8.4 Standard Deviation) |
| Aflibercept Extended Dosing | -0.3 Letters read correctly (±7.5 Standard Deviation) | |||
| NCT02634333 | Diabetic Retinopathy | Change in Visual Acuity From Baseline 2 years | Aflibercept | -0.9 Letter Score (±5.8 Standard Deviation) |
| Aflibercept | -2.7 Letter Score (±6.5 Standard Deviation) | |||
| Sham | -2.4 Letter Score (±5.8 Standard Deviation) | |||
| Sham | -2.0 Letter Score (±6.1 Standard Deviation) | |||
| NCT02634333 | Diabetic Retinopathy | Development of PDR and/or DME (Whichever Came First) 2 years | Aflibercept | 27 Eyes |
| Aflibercept | 54 Eyes | |||
| Sham | 97 Eyes | |||
| Sham | 75 Eyes | |||
| NCT02718326 PANORAMA | — | Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups At Week 24 | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 58.4 Percentage of participants |
| Intravitreal Aflibercept Injection (IAI) 2Q16 | 61.5 Percentage of participants | |||
| Intravitreal Aflibercept Injection (IAI) 2Q8 | 55.2 Percentage of participants | |||
| Sham Treatment | 6.0 Percentage of participants | |||
| NCT02718326 PANORAMA | — | Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline At Week 52 | Intravitreal Aflibercept Injection (IAI) 2Q16 | 65.2 Percentage of participants |
| Intravitreal Aflibercept Injection (IAI) 2Q8 | 79.9 Percentage of participants | |||
| Sham Treatment | 15.0 Percentage of participants | |||
| NCT02818998 VIOLET | Macular Edema | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 From baseline to Week 52 | Aflibercept 2 mg Extended | 0.5 Scores on a scale (±6.7 Standard Deviation) |
| Aflibercept 2 mg Fixed | 0.4 Scores on a scale (±6.7 Standard Deviation) | |||
| Aflibercept 2 mg PRN | 1.7 Scores on a scale (±6.8 Standard Deviation) | |||
| NCT02858076 AB | Vitreous Hemorrhage | E-ETDRS Visual Acuity Letter Score (Area Under the Curve From Baseline) 24 weeks | Intravitreous 2 mg Aflibercept Injections | 68.7 units on a scale (±15.0 Standard Deviation) |
| Intravitreous 2 mg Aflibercept Injections | 59.3 units on a scale (±21.9 Standard Deviation) | |||
| Prompt Vitrectomy Plus Panretinal Photocoagulation | 70.0 units on a scale (±18.8 Standard Deviation) | |||
| Prompt Vitrectomy Plus Panretinal Photocoagulation | 63.0 units on a scale (±21.7 Standard Deviation) | |||
| NCT02980874 SAPPHIRE | Macular Edema | Proportion of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) 2 months | Active | 114 Participants |
| Control | 127 Participants | |||
| NCT03321513 DRCR AC | — | Mean Change in Visual Acuity 2 years | Aflibercept- Monotherapy Group | 15 Letter Score (±8.5 Standard Deviation) |
| Bevacizumab-First Group | 14 Letter Score (±8.8 Standard Deviation) | |||
| NCT03386474 | — | Number of Participants With Ocular and Non-Ocular Treatment Emergent Adverse Events Up to Week 24 | Brolucizumab - Overall Extension Study | 20 Participants |
| Brolucizumab - Overall Extension Study | 51 Participants | |||
| Brolucizumab Overall Last 6 Months From Core Study | 25 Participants | |||
| Brolucizumab Overall Last 6 Months From Core Study | 50 Participants | |||
| NCT03481634 KESTREL | Diabetic Retinopathy | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 Baseline, Week 52 | Aflibercept 2 mg | 10.6 Scores on a scale (±0.67 Standard Error) |
| Aflibercept 2 mg | 10.5 Scores on a scale (±0.57 Standard Error) | |||
| Brolucizumab 3 mg | 7.3 Scores on a scale (±0.66 Standard Error) | |||
| Brolucizumab 6 mg | 9.2 Scores on a scale (±0.57 Standard Error) | |||
| NCT03481660 KITE | — | Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 for the Study Eye Baseline, Week 52 | Aflibercept 2 mg | 9.4 Scores on a scale |
| Brolucizumab 6 mg | 10.6 Scores on a scale | |||
| NCT03622580 | — | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations From Baseline through Week 56 | A: Faricimab 6 mg Q8W | 10.7 ETDRS Letters |
| A: Faricimab 6 mg Q8W | 10.6 ETDRS Letters | |||
| B: Faricimab 6 mg PTI | 11.6 ETDRS Letters | |||
| B: Faricimab 6 mg PTI | 11.4 ETDRS Letters | |||
| C: Aflibercept 2 mg Q8W | 11.3 ETDRS Letters | |||
| C: Aflibercept 2 mg Q8W | 10.9 ETDRS Letters | |||
| NCT03622593 RHINE | — | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations From Baseline through Week 56 | A: Faricimab 6 mg Q8W | 11.7 ETDRS Letters |
| A: Faricimab 6 mg Q8W | 11.8 ETDRS Letters | |||
| B: Faricimab 6 mg PTI | 10.8 ETDRS Letters | |||
| B: Faricimab 6 mg PTI | 11.2 ETDRS Letters | |||
| C: Aflibercept 2 mg Q8W | 10.3 ETDRS Letters | |||
| C: Aflibercept 2 mg Q8W | 10.5 ETDRS Letters | |||
| NCT03639675 VENERA | Glaucoma, Neovascular | Change in Intraocular Pressure (IOP) From Baseline to Week 1 Baseline and week 1 | Aflibercept 2 mg Intravitreal (IVT) Injection Group | -8.3 mmHg (±7.3 Standard Deviation) |
| NCT03710564 MERLIN | Macular Degeneration | Change From Baseline in Best-Corrected Visual Acuity (BCVA) at Week 52 Baseline, week 52 | Aflibercept | 0.9 Score on a scale (±6.51 Standard Deviation) |
| Brolucizumab | 0.3 Score on a scale (±9.02 Standard Deviation) | |||
| NCT03802630 RAPTOR | Macular Edema | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 Baseline, Week 24 | Aflibercept 2 mg | 15.0 Letters read (±0.71 Standard Error) |
| Brolucizumab 6 mg | 13.1 Letters read (±0.71 Standard Error) | |||
| NCT03810313 RAVEN | Macular Edema | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 24 Baseline, Week 24 | Aflibercept 2 mg | 16.0 Letters read (±0.85 Standard Error) |
| Brolucizumab 6 mg | 13.2 Letters read (±0.85 Standard Error) | |||
| NCT03823287 | Wet Macular Degeneration | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 From Baseline through Week 48 | Arm A: Faricimab | 5.8 ETDRS Letters |
| Arm B: Aflibercept | 5.1 ETDRS Letters | |||
| NCT03823300 | Wet Macular Degeneration | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48 From Baseline through Week 48 | Arm A: Faricimab | 6.6 ETDRS Letters |
| Arm B: Aflibercept | 6.6 ETDRS Letters | |||
| NCT03917472 KINGFISHER | Diabetic Retinopathy | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 52 Baseline, Week 52 | Aflibercept 2mg q4w | 11.0 Scores on a scale |
| Brolucizumab 6mg q4w | 12.2 Scores on a scale | |||
| NCT04004208 FIREFLEYE | Retinopathy of Prematurity | Proportion of Participants With Absence of Active ROP and Unfavorable Structural Outcomes At 24 weeks after starting study treatment | Aflibercept 0.4 mg | 0.855 Proportion of participants |
| Laser Photocoagulation | 0.821 Proportion of participants | |||
| NCT04005352 TALON | Macular Degeneration | Average Change From Baseline at Week 28 and Week 32 in Best-corrected Visual Acuity (BCVA) - Study Eye Baseline, Week 28 and Week 32 | Aflibercept 2 mg | 5.1 Scores on a scale (±0.51 Standard Error) |
| Brolucizumab 6 mg | 5.2 Scores on a scale (±0.51 Standard Error) | |||
| NCT04005352 TALON | Macular Degeneration | Distribution of the Last Interval With no Disease Activity up to Week 32 - Study Eye Up to Week 32 | Aflibercept 2 mg | 148 Participants |
| Aflibercept 2 mg | 147 Participants | |||
| Aflibercept 2 mg | 73 Participants | |||
| Brolucizumab 6 mg | 141 Participants | |||
| Brolucizumab 6 mg | 94 Participants | |||
| Brolucizumab 6 mg | 131 Participants | |||
| NCT04047472 | Macular Degeneration | Change From Baseline at Week 48 in Best-Corrected Visual Acuity in Study Eye Baseline, Week 48 | Aflibercept 2 mg | 10.9 Letters Read (±0.82 Standard Error) |
| Brolucizumab 6 mg | 9.9 Letters Read (±0.82 Standard Error) | |||
| NCT04049266 DAZZLE | Macular Degeneration | Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48 and 52, Full Analysis Set Year 1 Year 1 | Aflibercept 2 mg Q8W | 7 ETDRS Letters (±0.77 Standard Error) |
| KSI-301 5 mg Q12W-Q20W | 1 ETDRS Letters (±0.78 Standard Error) | |||
| NCT04058067 KINGLET | Diabetic Retinopathy | Best-corrected Visual Acuity (BCVA) - Average Change From Baseline Over the Period Week 40 Through Week 52 for the Study Eye Week 40 to Week 52 | Aflibercept 2 mg | 12.0 Scores on a scale (±0.82 Standard Error) |
| Brolucizumab 6 mg | 10.1 Scores on a scale (±0.81 Standard Error) | |||
| NCT04058067 KINGLET | Diabetic Retinopathy | Change From Baseline at Week 52 in Best-corrected Visual Acuity (BCVA) for the Study Eye. Baseline to Week 52 | Aflibercept 2 mg | 11.9 Scores on a scale (±0.85 Standard Error) |
| Brolucizumab 6 mg | 10.6 Scores on a scale (±0.85 Standard Error) | |||
| NCT04101721 BUTTERFLEYE | Retinopathy of Prematurity | Percentage of Participants With Absence of Active Retinopathy of Prematurity (ROP) and Unfavorable Structural Outcomes From Baseline to Week 52 of Chronological Age Baseline to week 52 of chronological age | Aflibercept 0.4 mg | 79.6 Percentage of participants |
| Laser Photocoagulation | 77.8 Percentage of participants | |||
| NCT04270747 | Macular Degeneration | Mean Change From Baseline in BCVA at Week 8 Baseline and Week 8 | ABP 938 | 6.4 Letters (±8.18 Standard Deviation) |
| Aflibercept | 6.5 Letters (±8.97 Standard Deviation) | |||
| NCT04423718 PULSAR | — | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 48 At baseline and Week 48 | Aflibercept 2q8 | 7.03 scores on a scale (±0.74 Standard Error) |
| Aflibercept HDq12 | 6.06 scores on a scale (±0.77 Standard Error) | |||
| Aflibercept HDq16 | 5.89 scores on a scale (±0.72 Standard Error) | |||
| NCT04429503 PHOTON | Diabetes Mellitus, Type 1 | Change From Baseline in Best Corrected Visual Acuity (BCVA) (Early Treatment Diabetic Retinopathy Study [ETDRS] Letter Score) in the Study Eye at Week 48 Baseline, Week 48 | Aflibercept 2 mg Every 8 Weeks (2q8) | 8.67 Letters (±0.73 Standard Error) |
| HD Aflibercept Every 16 Weeks (HDq16) | 7.23 Letters (±0.71 Standard Error) | |||
| High-dose (HD) Aflibercept Every 12 Weeks (HDq12) | 8.10 Letters (±0.61 Standard Error) | |||
| NCT04450329 | — | Change From Baseline in Best Corrected Visual Acuity (BCVA) Baseline and Week 8 | Eylea (Aflibercept) | 6.6 letters (±0.57 Standard Error) |
| SB15 (Proposed Aflibercept Biosimilar) | 6.7 letters (±0.56 Standard Error) | |||
| NCT04480463 | Macular Degeneration | Change From Baseline in BCVA (Best Corrected Visual Acuity) Baseline to Week 8 | Aflibercept | 7.7 Letters correctly read |
| Aflibercept | 5.9 Letters correctly read | |||
| SCD411 | 5.5 Letters correctly read | |||
| SCD411 | 9.0 Letters correctly read | |||
| NCT04522167 MAGELLAN-AMD | — | Evaluate and Compare Functional Changes in Best Corrected Visual Acuity (BCVA) by Early Treatment Diabetic Retinopathy Study (ETDRS) Letters at Week 8 of Treatment With FYB203 or Eylea Compared to Baseline. Week 8 | Eylea® (Aflibercept) | 5.6 letters (±0.73 Standard Error) |
| FYB203 (Proposed Aflibercept Biosimilar) | 6.6 letters (±0.73 Standard Error) | |||
| NCT04592419 BEACON | Macular Edema | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. Day 1 to Week 24 | Aflibercept (Arm B) | 15.5 ETDRS Letters (±.81 Standard Error) |
| KSI-301 (Arm A) | 13.0 ETDRS Letters (±.83 Standard Error) | |||
| NCT04592419 BEACON | Macular Edema | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. Day 1 to Week 24 | Aflibercept (Arm B) | 15.6 ETDRS Letters (±.79 Standard Error) |
| KSI-301 (Arm A) | 14.2 ETDRS Letters (±.81 Standard Error) | |||
| NCT04603937 GLIMMER | Diabetic Retinopathy | Mean Change in BCVA Day 1 to Week 64 | Aflibercept (Arm B) | 11.5 ETDRS Letters (±0.81 Standard Error) |
| KSI-301 (Arm A) | 6.7 ETDRS Letters (±0.80 Standard Error) | |||
| NCT04611152 GLEAM | Diabetic Retinopathy | Mean Change in BCVA Day 1 to Week 64 | Aflibercept (Arm B) | 9.5 ETDRS Letters (±0.85 Standard Error) |
| KSI-301 (Arm A) | 5.6 ETDRS Letters (±0.83 Standard Error) | |||
| NCT04740905 BALATON | Macular Edema | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 From Baseline through Week 24 | Arm A: Faricimab Q4W (Part 1) | 16.9 ETDRS Letters |
| Arm B: Aflibercept Q4W (Part 1) | 17.5 ETDRS Letters | |||
| NCT04740931 COMINO | Macular Edema | Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24 From Baseline through Week 24 | Arm A: Faricimab Q4W (Part 1) | 16.9 ETDRS Letters |
| Arm B: Aflibercept Q4W (Part 1) | 17.3 ETDRS Letters | |||
| NCT04757636 COAST | Macular Degeneration | Mean Change in Early Treatment Retinopathy Study (ETDRS) Best-corrected Visual Acuity (BCVA) Letters Baseline to Week 52 | 2.0 mg Aflibercept With Extended Dosing 2.0 mg OPT-302 | 12.82 Letters read (±0.728 Standard Error) |
| 2.0 mg Aflibercept With Sham | 13.66 Letters read (±0.728 Standard Error) | |||
| 2.0 mg Aflibercept With Standard Dosing 2.0 mg OPT-302 | 13.48 Letters read (±0.729 Standard Error) | |||
| NCT04964089 DAYLIGHT | Macular Degeneration | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to the Average of Non-missing BCVA Values of Weeks 40, 44 and 48. Day 1 to Week 48 | Aflibercept (Treatment Group B) | 4.6 ETDRS Letters (±0.76 Standard Error) |
| KSI-301 (Treatment Group A) | 2.5 ETDRS Letters (±0.78 Standard Error) | |||
| NCT05704725 | — | Percentage of IVT Injections Successfully Administered Day of IVT injection (study day 1) | ABP 938 | 100 Percentage of Successful Injections |
| Aflibercept | 100 Percentage of Successful Injections | |||
| NCT05850520 QUASAR | — | Change From Baseline in BCVA Measured by the ETDRS Letter Score at Week 36 At Week 36 | Aflibercept 2q4 | 17.5 Letters (±0.7 Standard Error) |
| Aflibercept 8q8/3 | 17.4 Letters (±0.7 Standard Error) | |||
| Aflibercept 8q8/5 | 18.3 Letters (±0.6 Standard Error) |