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

Primary Purpose

Age-related Macular Degeneration

Status

Completed

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

ranibizumab

Conbercept

About this trial

This is an interventional basic science trial for Age-related Macular Degeneration focused on measuring Age-related macular degeneration,, ranibizumab,, conbercept,, plasma VEGF, PK

Eligibility Criteria

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Inclusion Criteria:

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

Exclusion Criteria:

For both eyes

Any active periocular or ocular infection or inflammation
Uncontrolled glaucoma
Neovascularization of the iris or neovascular glaucoma. For study eye
Choroidal neovascularization of any other cause than wet AMD
Ocular disorders present that may confound interpretation of study results,
Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy.
Structural damage within 0.5 disc diameter of the center of the macula
Atrophy or fibrosis involving the center of the fovea.
Inability of obtaining required lab report. Ocular medical history
History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment
Any type of systemic disease or its treatment
Any patients diagnosed with tumor.
Stroke or myocardial infarction less than 3 months.
Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation.
Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient
Patients who have participated in other investigational drug study within 60 days.
Pregnant or nursing (lactating) women.
Inability to comply with study or follow-up procedures.

Sites / Locations

Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ranibizumab 0.5 mg

Conbercept 0.5 mg

Arm Description

Three monthly injections of 0.5mg Ranibizumab

Three monthly injections of 0.5mg Conbercept

Outcomes

Primary Outcome Measures

Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at 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

Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at 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

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

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

Full Information

NCT ID

NCT02577107

First Posted

July 30, 2015

Last Updated

July 9, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02577107

Brief Title

Head to Head Study of Anti-VEGF Treatment.

Acronym

RELIANCE

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Completed

Study Start Date

January 13, 2016 (Actual)

Primary Completion Date

July 9, 2016 (Actual)

Study Completion Date

July 9, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Age-related Macular Degeneration

Keywords

Age-related macular degeneration,, ranibizumab,, conbercept,, plasma VEGF, PK

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Ranibizumab 0.5 mg

Arm Type

Experimental

Arm Description

Three monthly injections of 0.5mg Ranibizumab

Arm Title

Conbercept 0.5 mg

Arm Type

Active Comparator

Arm Description

Three monthly injections of 0.5mg Conbercept

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Type

Drug

Intervention Name(s)

Conbercept

Other Intervention Name(s)

Langmu

Primary Outcome Measure Information:

Title

Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)

Description

Time Frame

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

Title

Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection

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

Title

Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection

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

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Written informed consent must be obtained before any assessment is performed. Male or female patient ≥ 50 years of age. Subfoveal CNV secondary to nAMD. BCVA score must be between 73 and 24 letters as measured by ETDRS chart Exclusion Criteria: For both eyes Any active periocular or ocular infection or inflammation Uncontrolled glaucoma Neovascularization of the iris or neovascular glaucoma. For study eye Choroidal neovascularization of any other cause than wet AMD Ocular disorders present that may confound interpretation of study results, Previous treatment with verteporfin PDT (Visudyne®), external-beam radiation therapy, focal laser photocoagulation, vitrectomy, submacular surgery, or transpupillary thermotherapy. Structural damage within 0.5 disc diameter of the center of the macula Atrophy or fibrosis involving the center of the fovea. Inability of obtaining required lab report. Ocular medical history History of intravitreal injection with any anti-VEGF drugs within 3 months. Exclusion criteria for systemic medical conditions and treatment Any type of systemic disease or its treatment Any patients diagnosed with tumor. Stroke or myocardial infarction less than 3 months. Known hypersensitivity to indocyanine green, fluorescein, or any component of the investigational drug formulation. Use of any systemic anti-VEGF drugs within 6 months. Exclusion criteria for patient Patients who have participated in other investigational drug study within 60 days. Pregnant or nursing (lactating) women. Inability to comply with study or follow-up procedures.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610041

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing 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

Learn more about this trial

Head to Head Study of Anti-VEGF Treatment.

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