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

East Florida Eye Institute

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Age Related Macular Degeneration

Treatments: Drug: Aflibercept; Drug: Ranibizumab; Other: Control Group; Drug: Bevacizumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02296567

ML29189

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 10 patient groups

Group 1 Lucentis 4 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Group 2 Avastin 4 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab

Group 3 Eylea 4 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Treatment:

Drug: Aflibercept

Drug: Aflibercept

Drug: Aflibercept

Group 4 Lucentis 6 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Group 5 Avastin 6 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab

Group 6 Eylea 6 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Treatment:

Drug: Aflibercept

Drug: Aflibercept

Drug: Aflibercept

Group 7 Lucentis 8 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving ranibizumab following the first dose of standard care therapy.

Treatment:

Drug: Ranibizumab

Drug: Ranibizumab

Drug: Ranibizumab

Group 8 Avastin 8 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving bevacizumab following the first dose of standard care therapy.

Treatment:

Drug: Bevacizumab

Drug: Bevacizumab

Drug: Bevacizumab

Group 9 Eylea 8 weeks

Active Comparator group

Description:

Blood samples will be collected from patients receiving aflibercept following the first dose of standard care therapy.

Treatment:

Drug: Aflibercept

Drug: Aflibercept

Drug: Aflibercept

Group 10 Control Group no treatment

Active Comparator group

Description:

Blood samples will be collected from patients who are not receiving anti-VEGF treatment.

Treatment:

Other: Control Group