Clinical trial NCT02296567: Comparison of Pharmacokinetics of and Effect on Systemic VEGF Levels in Age Related Macular Degeneration Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Age Related Macular Degeneration
Lead sponsor: East Florida Eye Institute
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2014-11-20
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in serum and plasma levels of free Vascular Endothelial Growth Factor
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Change in Serum drug levels in nanomoles (nM) units following treatment
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Stuart
country: United States
facility: East Florida Eye Institute
state: Florida
Study officials:
affiliation: East Florida Eye Institute
name: Ronald E Frenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: