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Head to Head Study of Anti-VEGF Treatment. (RELIANCE)

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ClinicalTrials.gov Identifier: NCT02577107
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : November 30, 2017
Last Update Posted : November 30, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Age-related Macular Degeneration
Interventions Drug: ranibizumab
Drug: Conbercept
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description Three monthly injections of 0.5mg Ranibizumab Three monthly injections of 0.5mg Conbercept
Period Title: Overall Study
Started 6 6
Completed 6 5
Not Completed 0 1
Reason Not Completed
Protocol deviation             0             1
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg Total
Hide Arm/Group Description Three monthly injections of 0.5mg Ranibizumab Three monthly injections of 0.5mg Conbercept Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
65.3  (5.50) 69.3  (8.41) 67.3  (7.09)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
0
   0.0%
1
  16.7%
1
   8.3%
Male
6
 100.0%
5
  83.3%
11
  91.7%
1.Primary Outcome
Title Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)
Hide Description 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.
Time Frame Baseline, Visit 5 (Day 8 +/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description:
Three monthly injections of 0.5mg Ranibizumab
Three monthly injections of 0.5mg Conbercept
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: pg/mL
5.720  (9.5547) -25.833  (22.8145)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ranibizumab 0.5 mg, Conbercept 0.5 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 20.314
Confidence Interval (2-Sided) 95%
9.618 to 31.011
Parameter Dispersion
Type: Standard Error of the Mean
Value: 4.1613
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)
Hide Description 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.
Time Frame Baseline, Visit 10 (Day 67 +/- 1 day)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description:
Three monthly injections of 0.5mg Ranibizumab
Three monthly injections of 0.5mg Conbercept
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: pg/mL
-0.100  (17.4799) -22.220  (12.9239)
3.Secondary Outcome
Title Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection
Hide Description 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
Time Frame Baseline, Visit 2, 3, 4, 5, 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description:
Three monthly injections of 0.5mg Ranibizumab
Three monthly injections of 0.5mg Conbercept
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 31.400  (6.3816) 42.200  (23.4269)
Visit 2 (Day 1) 30.958  (19.9813) 14.920  (12.4920)
Visit 3 (Day 2 +/- 1) 36.517  (19.2783) 24.590  (39.2435)
Visit 4 (Day 4 +/- 1) 29.150  (5.5587) 7.213  (4.9250)
Visit 5 (Day 8 +/- 1) 37.000  (4.7979) 19.075  (4.5051)
Visit 6 (Day 30 +/- 4) 27.092  (13.2356) 25.270  (15.0967)
4.Secondary Outcome
Title Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection
Hide Description 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
Time Frame Baseline, Visit 7, 8, 9, 10, 11
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set refers to all subjects who completed the study without any major deviation from the study protocol.
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description:
Three monthly injections of 0.5mg Ranibizumab
Three monthly injections of 0.5mg Conbercept
Overall Number of Participants Analyzed 6 5
Mean (Standard Deviation)
Unit of Measure: pg/mL
Baseline 36.250  (11.8610) 36.520  (19.2278)
Visit 7 (Day 60 +/- 4) 34.383  (12.7727) 5.720  (2.1690)
Visit 8 (Day 61 +/- 1) 46.533  (48.1293) 6.820  (4.6287)
Visit 9 (Day 63 +/- 1) 54.067  (40.2585) 8.070  (4.6452)
Visit 10 (Day 67 +/- 1) 36.150  (25.4399) 14.300  (9.6690)
Visit 11 (Day 90 +/- 4) 45.067  (18.0828) 56.020  (27.0819)
Time Frame 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.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ranibizumab 0.5 mg Conbercept 0.5 mg
Hide Arm/Group Description Three monthly injections of 0.5mg Ranibizumab Three monthly injections of 0.5mg Conbercept
All-Cause Mortality
Ranibizumab 0.5 mg Conbercept 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ranibizumab 0.5 mg Conbercept 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   2/6 (33.33%) 
Infections and infestations     
Infectious pneumonia  1  0/6 (0.00%)  1/6 (16.67%) 
Injury, poisoning and procedural complications     
Craniocerebral injury  1  0/6 (0.00%)  1/6 (16.67%) 
Fracture of jaw  1  0/6 (0.00%)  1/6 (16.67%) 
Fracture of rib  1  0/6 (0.00%)  1/6 (16.67%) 
Pulmonary contusion  1  0/6 (0.00%)  1/6 (16.67%) 
Thoracic injury  1  0/6 (0.00%)  1/6 (16.67%) 
Respiratory, thoracic and mediastinal disorders     
COPD  1  0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ranibizumab 0.5 mg Conbercept 0.5 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   3/6 (50.00%) 
Ear and labyrinth disorders     
Dizziness  1  0/6 (0.00%)  1/6 (16.67%) 
Eye disorders     
Conjunctival congestion  1  0/6 (0.00%)  1/6 (16.67%) 
Infections and infestations     
Upper respiratory infection  1  1/6 (16.67%)  1/6 (16.67%) 
Nervous system disorders     
Headache  1  0/6 (0.00%)  1/6 (16.67%) 
Migraine  1  1/6 (16.67%)  0/6 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/6 (0.00%)  1/6 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (19.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT02577107     History of Changes
Other Study ID Numbers: CRFB002ACN07
First Submitted: July 30, 2015
First Posted: October 16, 2015
Results First Submitted: July 9, 2017
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017