Trial Outcomes & Findings for Head to Head Study of Anti-VEGF Treatment. (NCT NCT02577107)

NCT ID: NCT02577107

Last Updated: 2017-11-30

Results Overview

Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after first injection at Visit 5 (Day 8 +/- 1 day).Blood sample was collected for systemic VEGF. VEGF was measured by a blinded laboratory using ELISA kits.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: Baseline, Visit 5 (Day 8 +/- 1 day)
• Results posted on: 2017-11-30

Participant Flow

Participant milestones

Measure	Ranibizumab 0.5 mg Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg Three monthly injections of 0.5mg Conbercept
Overall Study STARTED	6	6
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Ranibizumab 0.5 mg Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg Three monthly injections of 0.5mg Conbercept
Overall Study Protocol deviation	0	1

Baseline Characteristics

Head to Head Study of Anti-VEGF Treatment.

Baseline characteristics by cohort

Measure	Ranibizumab 0.5 mg n=6 Participants Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=6 Participants Three monthly injections of 0.5mg Conbercept	Total n=12 Participants Total of all reporting groups
Age, Continuous	65.3 years STANDARD_DEVIATION 5.50 • n=5 Participants	69.3 years STANDARD_DEVIATION 8.41 • n=7 Participants	67.3 years STANDARD_DEVIATION 7.09 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Visit 5 (Day 8 +/- 1 day)

Population: Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.

Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after first injection at Visit 5 (Day 8 +/- 1 day).Blood sample was collected for systemic VEGF. VEGF was measured by a blinded laboratory using ELISA kits.

Outcome measures

Measure	Ranibizumab 0.5 mg n=6 Participants Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=5 Participants Three monthly injections of 0.5mg Conbercept
Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)	5.720 pg/mL Standard Deviation 9.5547	-25.833 pg/mL Standard Deviation 22.8145

SECONDARY outcome

Timeframe: Baseline, Visit 10 (Day 67 +/- 1 day)

Population: Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.

Change from baseline in plasma Vascular endothelial growth factor (VEGF) concentration after third injection at Visit 10 (Day 67 +/- 1 day). Blood sample was collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits.

Outcome measures

Measure	Ranibizumab 0.5 mg n=6 Participants Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=5 Participants Three monthly injections of 0.5mg Conbercept
Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)	-0.100 pg/mL Standard Deviation 17.4799	-22.220 pg/mL Standard Deviation 12.9239

SECONDARY outcome

Timeframe: Baseline, Visit 2, 3, 4, 5, 6

Population: Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.

Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit Visit 2, 3, 4, 5, 6 after 1st injection

Outcome measures

Measure	Ranibizumab 0.5 mg n=6 Participants Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=5 Participants Three monthly injections of 0.5mg Conbercept
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Baseline	31.400 pg/mL Standard Deviation 6.3816	42.200 pg/mL Standard Deviation 23.4269
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Visit 2 (Day 1)	30.958 pg/mL Standard Deviation 19.9813	14.920 pg/mL Standard Deviation 12.4920
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Visit 3 (Day 2 +/- 1)	36.517 pg/mL Standard Deviation 19.2783	24.590 pg/mL Standard Deviation 39.2435
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Visit 4 (Day 4 +/- 1)	29.150 pg/mL Standard Deviation 5.5587	7.213 pg/mL Standard Deviation 4.9250
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Visit 5 (Day 8 +/- 1)	37.000 pg/mL Standard Deviation 4.7979	19.075 pg/mL Standard Deviation 4.5051
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection Visit 6 (Day 30 +/- 4)	27.092 pg/mL Standard Deviation 13.2356	25.270 pg/mL Standard Deviation 15.0967

SECONDARY outcome

Timeframe: Baseline, Visit 7, 8, 9, 10, 11

Population: Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.

Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Baseline, Visit 7, 8, 9, 10, 11 after 3rd injection

Outcome measures

Measure	Ranibizumab 0.5 mg n=6 Participants Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=5 Participants Three monthly injections of 0.5mg Conbercept
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Baseline	36.250 pg/mL Standard Deviation 11.8610	36.520 pg/mL Standard Deviation 19.2278
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Visit 7 (Day 60 +/- 4)	34.383 pg/mL Standard Deviation 12.7727	5.720 pg/mL Standard Deviation 2.1690
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Visit 8 (Day 61 +/- 1)	46.533 pg/mL Standard Deviation 48.1293	6.820 pg/mL Standard Deviation 4.6287
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Visit 9 (Day 63 +/- 1)	54.067 pg/mL Standard Deviation 40.2585	8.070 pg/mL Standard Deviation 4.6452
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Visit 10 (Day 67 +/- 1)	36.150 pg/mL Standard Deviation 25.4399	14.300 pg/mL Standard Deviation 9.6690
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection Visit 11 (Day 90 +/- 4)	45.067 pg/mL Standard Deviation 18.0828	56.020 pg/mL Standard Deviation 27.0819

Adverse Events

Ranibizumab 0.5 mg

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Conbercept 0.5 mg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Ranibizumab 0.5 mg n=6 participants at risk Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=6 participants at risk Three monthly injections of 0.5mg Conbercept
Infections and infestations Infectious pneumonia	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Craniocerebral injury	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Fracture of jaw	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Fracture of rib	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Pulmonary contusion	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Injury, poisoning and procedural complications Thoracic injury	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders COPD	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Other adverse events

Measure	Ranibizumab 0.5 mg n=6 participants at risk Three monthly injections of 0.5mg Ranibizumab	Conbercept 0.5 mg n=6 participants at risk Three monthly injections of 0.5mg Conbercept
Ear and labyrinth disorders Dizziness	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Eye disorders Conjunctival congestion	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Infections and infestations Upper respiratory infection	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Headache	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Nervous system disorders Migraine	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.	16.7% 1/6 • Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit.

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862-778-8300

Results disclosure agreements

• Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
• Publication restrictions are in place

Restriction type: OTHER