Clinical trial NCT02577107: Head to Head Study of Anti-VEGF Treatment.
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Age-related Macular Degeneration
Keywords: Age-related macular degeneration,
ranibizumab,
conbercept,
plasma VEGF
PK
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-10-16
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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.

Primary outcomes:
measure: Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After First Injection at Visit 5 (Day 8 +/- 1 Day)
timeFrame: Baseline, Visit 5 (Day 8 +/- 1 day)
Secondary outcomes:
measure: Change From Baseline in Plasma Vascular Endothelial Growth Factor (VEGF) Concentration After Third Injection at Visit 10 (Day 67 +/- 1 Day)
timeFrame: Baseline, Visit 10 (Day 67 +/- 1 day)
measure: Plasma VEGF Concentration at Baseline, Visit 2, 3, 4, 5, 6 After 1st Injection
timeFrame: Baseline, Visit 2, 3, 4, 5, 6
measure: Plasma VEGF Concentration at Baseline, Visit 7, 8, 9, 10, 11 After 3rd Injection
timeFrame: Baseline, Visit 7, 8, 9, 10, 11
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Novartis Investigative Site
state: Sichuan
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: