Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients

Age Related Macular Degeneration Clinical Trial

Official title:

Comparison of Pharmacokinetics of and Effect on Systemic Vascular Endothelial Growth Factor (VEGF) Levels Over Time of Intravitreal Ranibizumab and Bevacizumab and Aflibercept in Age Related Macular Degeneration Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02296567
• Other study ID #: ML29189
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: November 5, 2014
• Last updated: August 7, 2015
• Start date: December 2014
• Est. completion date: July 2016

Study information

• Verified date: August 2015
• Source: East Florida Eye Institute
• Contact: Ronald E. Frenkel, MD
• Phone: 772.287.9000
• Email: info[@]efei.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To demonstrate the effects of Lucentis (ranibizumab), Avastin ( bevacizumab), and Eylea ( aflibercept) on the levels of naturally occurring Vascular Endothelial Growth Factor (VEGF) in the systemic circulation of Age Related Macular Degeneration patients currently treated with these medications.

Description:

To determine plasma levels of VEGF and serum Pharmacokinetic (PK) levels after varying lengths of time following intravitreal injection with Avastin, Lucentis, or Eylea in exudative macular degeneration. Patients will be tested while following a normal course of treatment in our institute. All screenings and testing will be conducted in three study visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Ability to provide written informed consent for participation in this study.

2. Adults = 50 years of age with exudative macular degeneration treated with Avastin, Lucentis, or Eylea in previously determined time intervals exclusive to a single anti-VEGF treatment type for not than three months.

3. CONTROL GROUP: Age matched control group with no previously diagnosed exudative macular degeneration will also be enrolled.

4. Provide signed informed consent.

Exclusion Criteria:

1. Uncontrolled blood pressure (defined as systolic > 160mm Hg or Diastolic > 95mm Hg while patient is sitting)

2. Uncontrolled diabetes mellitus defined by Hemoglobin A1c (HbA1C > 12% at screening)

3. Concomitant ocular or systemic administration of drugs that may interfere with or potentiate the mechanism of action of anti-VEGF medications.

4. Previous administration of systemic anti-angiogenic medications within 3 months

5. Participation in a simultaneous medical investigation or trial.

6. Treatment within 2 months with anti-VEGF agent in the fellow eye or anticipated need for further treatment during the study.

7. Patients with any cancer diagnosis in remission for less than five years with the exception that patients with skin cancers, basal cell or squamous cell, treated exclusively or topical treatment will be allowed.

8. Female patients who have not reached menopause, defined as cessation of menses for a minimum of twelve months with no perimenopausal symptoms.

9. Patients who have significant wound healing during the trial.

10. Patients with a history of vitrectomy in the study eye.

11. patients with uncontrolled psoriasis, rheumatoid arthritis, osteoarthritis.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
• Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
• Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
• Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
• Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
• Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
• Ranibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
• Bevacizumab
Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
• Aflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care

Other:
• Control Group
Control group Subjects will no previous anti-VEGF treatment

Locations

Country	Name	City	State
United States	East Florida Eye Institute	Stuart	Florida

Sponsors (2)

Lead Sponsor	Collaborator
East Florida Eye Institute	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum and plasma levels of free Vascular Endothelial Growth Factor	Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment.	up to 8 weeks	No
Secondary	Change in Serum drug levels in nanomoles (nM) units following treatment	Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment.	8 weeks	No
Secondary	Amount of fluid (cubic mm) as measured by Ocular Coherence Tomography in the contralateral eye will be correlated with systemic Vascular Endothelial Growth Factor levels		8 weeks	No