Age Related Macular Degeneration
Conditions
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.
Interventions
DRUGRanibizumab
Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
DRUGBevacizumab
Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
DRUGAflibercept
Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
OTHERControl Group
Control group Subjects will no previous anti-VEGF treatment
Sponsors
Genentech, Inc.
East Florida Eye Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum and plasma levels of free Vascular Endothelial Growth Factor | up to 8 weeks | Serum and plasma levels of free vascular endothelial growth factor will be measured up to 8 weeks following the standard of care treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Serum drug levels in nanomoles (nM) units following treatment | 8 weeks | Serum levels of Ranibizumab, Bevacizumab, or Aflibercept will be measured up to 8 weeks following the standard of care treatment. |
| 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 | — |
Countries
United States
Contacts
Primary ContactRonald E. Frenkel, MD
Outcome results
None listed