Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 )

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

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Drug: ranibizumab Drug: Conbercept Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Actual Study Start Date : January 13, 2016
Actual Primary Completion Date : July 9, 2016
Actual Study Completion Date : July 9, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab 0.5 mg
Three monthly injections of 0.5mg Ranibizumab
Drug: ranibizumab
Other Name: Lucentis

Active Comparator: Conbercept 0.5 mg
Three monthly injections of 0.5mg Conbercept
Drug: Conbercept
Other Name: Langmu




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577107


Locations
Layout table for location information
China, Sichuan
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02577107     History of Changes
Other Study ID Numbers: CRFB002ACN07
First Posted: October 16, 2015    Key Record Dates
Results First Posted: November 30, 2017
Last Update Posted: November 30, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
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


Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Age-related macular degeneration,
ranibizumab,
conbercept,
plasma VEGF
PK
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents