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



Status:Recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:4/21/2016
Start Date:December 2014
End Date:July 2016
Contact:Ronald E. Frenkel, MD
Email:info@efei.com
Phone:772.287.9000

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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

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.

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.

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.
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Stuart, Florida 34994
Phone: 772-287-9000
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