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

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: East Florida Eye Institute
• Collaborator: Genentech, Inc.
• Treatments: Aflibercept; Bevacizumab; Endothelial Growth Factors; Ranibizumab

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.