Head to Head Study of Anti-VEGF Treatment.

NCT02577107 | Completed Phase 4 Results

• 1 other identifier: CRFB002ACN07
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Age-related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

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

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

  Baseline, Visit 2, 3, 4, 5, 6

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

  Baseline, Visit 7, 8, 9, 10, 11

Study Arms (2)

Ranibizumab 0.5 mg

EXPERIMENTAL

Three monthly injections of 0.5mg Ranibizumab

Drug: ranibizumab

Conbercept 0.5 mg

ACTIVE COMPARATOR

Three monthly injections of 0.5mg Conbercept

Drug: Conbercept

Interventions

ranibizumab DRUG

Also known as: Lucentis

Ranibizumab 0.5 mg

Conbercept DRUG

Also known as: Langmu

Conbercept 0.5 mg

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.
• Patients who have participated in other investigational drug study within 60 days.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; KH902 fusion protein

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2015
• First Posted: October 16, 2015
• Study Start: January 13, 2016
• Primary Completion: July 9, 2016
• Study Completion: July 9, 2016
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-07

Locations

CN (1)