Head to Head Study of Anti-VEGF Treatment.

Phase 4

Completed

• Conditions: Age-related Macular Degeneration
• Interventions: Drug: ranibizumab; Drug: Conbercept

• Registration Number: NCT02577107
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-07-30
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-16
• Study Start: 2016-01-13
• Primary Completion: 2016-07-09
• Study Completion: 2016-07-09
• Status Verified: 2017-07
• Results First Submitted: 2017-07-09
• Results First Submitted QC: 2017-07-09
• Last Update Submitted: 2017-07-09
• Results First Posted: 2017-11-30
• Last Update Posted: 2017-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ranibizumab 0.5 mg	ranibizumab	Three monthly injections of 0.5mg Ranibizumab
Conbercept 0.5 mg	Conbercept	Three monthly injections of 0.5mg Conbercept

Primary Outcome Measures

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

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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇨🇳 Chengdu, Sichuan, China