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Head to Head Study of Anti-VEGF Treatment.

NCT ID: NCT02577107

Last Updated: 2017-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-13

Study Completion Date

2016-07-09

Brief Summary

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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

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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

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Age-related Macular Degeneration

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Ranibizumab 0.5 mg

Three monthly injections of 0.5mg Ranibizumab

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

Conbercept 0.5 mg

Three monthly injections of 0.5mg Conbercept

Group Type ACTIVE_COMPARATOR

Conbercept

Intervention Type DRUG

Interventions

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ranibizumab

Intervention Type DRUG

Conbercept

Intervention Type DRUG

Other Intervention Names

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Lucentis Langmu

Eligibility Criteria

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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
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.
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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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CRFB002ACN07

Identifier Type: -

Identifier Source: org_study_id