Age-related Macular DegenerationPhase 4RELIANCENCT02577107
Head to Head Study of Anti-VEGF Treatment.
A Phase 4 study testing ranibizumab and Conbercept in people with Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- ranibizumab and Conbercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 13 Jan 2016to 9 Jul 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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,
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
- Conditions
- Age-related Macular Degeneration
- Being tested
- ranibizumab, Conbercept
- Keywords
- Age-related macular degeneration,, ranibizumab,, conbercept,, plasma VEGF, PK
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ranibizumabDrug
Also called Lucentis
ConberceptDrug
Also called Langmu
| Study group | Role | What they receive |
|---|---|---|
| Ranibizumab 0.5 mg | Experimental | Three monthly injections of 0.5mg Ranibizumab Receives: Drug: ranibizumab |
| Conbercept 0.5 mg | Active comparator | Three monthly injections of 0.5mg Conbercept Receives: Drug: Conbercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Visit 5 (Day 8 +/- 1 day)
Secondary outcomes (3)
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.
Measured: Baseline, Visit 10 (Day 67 +/- 1 day)
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
Measured: Baseline, Visit 2, 3, 4, 5, 6
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
Measured: Baseline, Visit 7, 8, 9, 10, 11
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study start13 Jan 2016
- Primary completion9 Jul 2016
- Study completion9 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577107
- Sponsor's protocol ID
- CRFB002ACN07
- Acronym
- RELIANCE
- Status last verified
- Jul 2017
- First submitted
- 30 Jul 2015
- Last updated
- 30 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02577107
- Acronym / sponsor ID
- RELIANCE / CRFB002ACN07
- Conditions
- Age-related Macular Degeneration
- Keywords
- Age-related macular degeneration,, ranibizumab,, conbercept,, plasma VEGF, PK
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 13 Jan 2016 (actual)
- Primary completion
- 9 Jul 2016 (actual)
- Study completion
- 9 Jul 2016 (actual)
- First posted
- 16 Oct 2015 (estimated)
- Results
- Posted 30 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ranibizumab 0.5 mg | Experimental | Drug: ranibizumabThree monthly injections of 0.5mg Ranibizumab |
| Conbercept 0.5 mg | Active comparator | Drug: ConberceptThree monthly injections of 0.5mg Conbercept |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ranibizumabAlso: Lucentis | Drug | Ranibizumab 0.5 mg |
| ConberceptAlso: Langmu | Drug | Conbercept 0.5 mg |
Primary outcome
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.
3 secondary outcomes
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)
Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection
Time frame: Baseline, Visit 2, 3, 4, 5, 6
Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection
Time frame: Baseline, Visit 7, 8, 9, 10, 11
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. 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
Related trials for Age-related Macular Degeneration
RecruitingPhase 3
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD
Neovascular Age-related Macular Degeneration
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
RecruitingObservational study
National Ophthalmic Genotyping and Phenotyping Network (eyeGENE (Registered Trademark)), Stage 3 - Expansion of DNA and Data Repositories for Rare Inherited Ophthalmic Diseases
Inherited Ophthalmic Diseases, Hypopigmentation Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ranibizumab and Conbercept in people with Age-related Macular Degeneration, run by Novartis Pharmaceuticals at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2017.