Systemic Pharmacokinetics Following Intravitreal Injections of Anti-VEGF

NCT02118831 | Completed Phase 1 Results

• 1 other identifier: ML28032
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

Comparable data for bevacizumab and aflibercept are lacking, as are studies comparing the systemic levels of ranibizumab, bevacizumab, and aflibercept and their relative effects on circulating vascular endothelial growth factor. In the present prospective study, the investigators evaluated serum drug levels and plasma free vascular endothelial growth factor (VEGF) levels in patients with neovascular age-related macular degeneration following intravitreal injections of ranibizumab, bevacizumab and aflibercept.

Conditions

Age-related Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Keywords

macular degeneration; diabetic macular edema; vein occlusion; vascular endothelial growth factor

Outcome Measures

Primary Outcomes (1)

• Serum Pharmacokinetics Following Treatment From 1st and 3rd Doses

  Maximum serum levels of ranibizumab, bevacizumab or aflibercept will be measured after the first and third injections, up to 28 days following each treatment.

  Up to 4 months

Secondary Outcomes (1)

• Change in Minimum Serum Levels of Free Vascular Endothelial Growth Factor From Baseline to Month 4 (One Month After Last Treatment)

  baseline and month 4

Study Arms (3)

Aflibercept Blood Sample Collection

ACTIVE COMPARATOR

Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.

Biological: Blood Sample Collection; Drug: Aflibercept

Bevacizumab Blood Sample Collection

ACTIVE COMPARATOR

Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.

Biological: Blood Sample Collection; Drug: Bevacizumab

Ranibizumab Blood Sample Collection

ACTIVE COMPARATOR

Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.

Biological: Blood Sample Collection; Drug: Ranibizumab

Interventions

Blood Sample Collection BIOLOGICAL

Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.

Aflibercept Blood Sample Collection; Bevacizumab Blood Sample Collection; Ranibizumab Blood Sample Collection

Aflibercept DRUG

an intravitreal injection of Aflibercept administered three times on a monthly basis.

Also known as: Eylea

Aflibercept Blood Sample Collection

Bevacizumab DRUG

an intravitreal injection of Bevacizumab administered three times on a monthly basis.

Also known as: Avastin

Bevacizumab Blood Sample Collection

Ranibizumab DRUG

an intravitreal injection of Ranibizumab administered three times on a monthly basis.

Also known as: Lucentis

Ranibizumab Blood Sample Collection

Eligibility Criteria

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

You may qualify if:

• Ability to provide written informed consent for participation in this study
• Subjects with a diagnosis of neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion who are either treatment naïve or more than 4 months out from a prior intravitreal anti-vascular endothelial growth factor injection

You may not qualify if:

• Subjects unwilling to receive 3 monthly injections of anti-vascular endothelial growth factor as initial therapy
• Subjects who may need or have received systemic anti-vascular endothelial growth factor for oncology in the past year
• Subjects with history of another ocular disease other than neovascular age-related macular degeneration, diabetic macular edema, or retinal vein occlusion
• Subjects with history of vitrectomy

Sponsors & Collaborators

• California Retina Consultants: lead

Related Publications (1)

• Avery RL, Castellarin AA, Steinle NC, Dhoot DS, Pieramici DJ, See R, Couvillion S, Nasir MA, Rabena MD, Le K, Maia M, Visich JE. Systemic pharmacokinetics following intravitreal injections of ranibizumab, bevacizumab or aflibercept in patients with neovascular AMD. Br J Ophthalmol. 2014 Dec;98(12):1636-41. doi: 10.1136/bjophthalmol-2014-305252. Epub 2014 Jul 7.

  PMID: 25001321 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Retinal Vein Occlusion

Interventions

aflibercept; Bevacizumab; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular 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: Director of Research
• Organization: California Retina Consultants

gabe@californiaretina.com

8059631648

Study Officials

• Robert L Avery, MD

  California Retina Consultants

  PRINCIPAL INVESTIGATOR

• Melvin D Rabena, BS

  California Retina Consultants

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 21, 2014
• Study Start: March 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: April 1, 2014
• Last Updated: May 19, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-04