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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date  ICMJE July 30, 2015
First Posted Date  ICMJE October 16, 2015
Results First Submitted Date  ICMJE July 9, 2017
Results First Posted Date  ICMJE November 30, 2017
Last Update Posted Date November 30, 2017
Actual Study Start Date  ICMJE January 13, 2016
Actual Primary Completion Date July 9, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2017)
Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day) [ Time Frame: Baseline, Visit 5 (Day 8 +/- 1 day) ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
Change from baseline to 7d post-injection in plasma VEGF concentration after dose 1 [ Time Frame: Baseline to 7d after dose 1 ]
Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits when 3h post-injection and 1d,3d,7d, 28d post-injection.Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
Change History Complete list of historical versions of study NCT02577107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2017)
  • Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day) [ Time Frame: Baseline, Visit 10 (Day 67 +/- 1 day) ]
    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.
  • Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection [ Time Frame: Baseline, Visit 2, 3, 4, 5, 6 ]
    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
  • Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection [ Time Frame: Baseline, Visit 7, 8, 9, 10, 11 ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 13, 2015)
  • Change from baseline to 3h post-injection in plasma VEGF concentration after dose 3 [ Time Frame: Baseline to 3h after dose 3 ]
    Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
  • Change from baseline to 1d post-injection in plasma VEGF concentration after dose 3 [ Time Frame: Baseline to 1d after dose 3 ]
    Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
  • Change from baseline to 3d post-injection in plasma VEGF concentration after dose 3 [ Time Frame: Baseline to 3d after dose 3 ]
    Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
  • Change from baseline to 7d post-injection in plasma VEGF concentration after dose 3 [ Time Frame: Baseline to 7d after dose 3 ]
    Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
  • Change from baseline to 28d post-injection in plasma VEGF concentration after dose 3 [ Time Frame: Baseline to 28d after dose 3 ]
    Blood sample will be collected for systemic VEGF. VEGF will be measured by a blinded laboratory using ELISA kits. Descriptive summary statistics including mean, standard deviation, median, minimum and maximum values will be presented.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Head to Head Study of Anti-VEGF Treatment.
Official Title  ICMJE An Exploratory Single Site, Open Label, Randomized, Controlled Study to Evaluate Plasma Vascular Endothelial Growth Factor Levels After Intravitreal Injection of Ranibizumab (Lucentis) and Conbercept (Langmu) for nAMD
Brief Summary An exploratory single site, open label, randomized, controlled study evaluated plasma vascular endothelial growth factor levels after intravitreal injection of ranibizumab (Lucentis) and conbercept (Langmu) for neovascular age-related macular degeneration
Detailed Description

This prospective, randomized, open label study enrolled patients with neovascular AMD who were naïve to anti-VEGF therapy or have not received intravitreal anti-VEGF therapy for the previous 3 months. Patients were randomized in two treatment arms for 3 months:

  • Study arm 1: Three monthly injections of 0.5mg Ranibizumab
  • Study arm 2: Three monthly injections of 0.5mg Conbercept Blood sample (plasma/serum) was collected at baseline (pre-dose), 3h post-injections and days 1, 3, 7 and 28, following doses 1 and 3 for PK and systemic VEGF analysis. The lab staff was blinded for treatment allocation.

Plasma VEGF concentration was measured by a blinded laboratory using Quantikine® ELISA kits. Serum ranibizumab and conbercept concentration will be determined using validated ELISA assay.

The study was divided into 2 stages: the 1st initial feasibility stage with 6 patients per arm (12 patients in total) to verify SD for sample size justification and 2nd stage to confirm the findings with justified sample size.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE
  • Drug: ranibizumab
    Other Name: Lucentis
  • Drug: Conbercept
    Other Name: Langmu
Study Arms  ICMJE
  • Experimental: Ranibizumab 0.5 mg
    Three monthly injections of 0.5mg Ranibizumab
    Intervention: Drug: ranibizumab
  • Active Comparator: Conbercept 0.5 mg
    Three monthly injections of 0.5mg Conbercept
    Intervention: Drug: Conbercept
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 13, 2015)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 9, 2016
Actual Primary Completion Date July 9, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written informed consent must be obtained before any assessment is performed.
  2. Male or female patient ≥ 50 years of age.
  3. Subfoveal CNV secondary to nAMD.
  4. BCVA score must be between 73 and 24 letters as measured by ETDRS chart

Exclusion Criteria:

For both eyes

  1. Any active periocular or ocular infection or inflammation
  2. Uncontrolled glaucoma
  3. Neovascularization of the iris or neovascular glaucoma. For study eye
  4. Choroidal neovascularization of any other cause than wet AMD
  5. Ocular disorders present that may confound interpretation of study results,
  6. Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
  7. Structural damage within 0.5 disc diameter of the center of the macula
  8. Atrophy or fibrosis involving the center of the fovea.
  9. Inability of obtaining required lab report. Ocular medical history
  10. History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
  11. Any type of systemic disease or its treatment
  12. Any patients diagnosed with tumor.
  13. Stroke or myocardial infarction less than 3 months.
  14. Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
  15. Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
  16. Patients who have participated in other investigational drug study within 60 days.
  17. Pregnant or nursing (lactating) women.
  18. Inability to comply with study or follow-up procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02577107
Other Study ID Numbers  ICMJE CRFB002ACN07
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP