Recruiting
Phase 2
Phase 3

Observational Study

Sponsor:

East Florida Eye Institute

Code:

NCT02296567

Conditions

Age Related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Ranibizumab

Bevacizumab

Aflibercept

Ranibizumab

Bevacizumab

Study Details

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.

Conditions

Age Related Macular Degeneration

Study ID

NCT02296567

Start date

Dec, 2014

Status verified date

Aug, 2015

Completion date

Jul, 2016

Anticipated

Primary completion date

Jul, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Group 1 Lucentis 4 weeks

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

active comparator: Group 2 Avastin 4 weeks

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

active comparator: Group 3 Eylea 4 weeks

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

active comparator: Group 4 Lucentis 6 weeks

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

active comparator: Group 5 Avastin 6 weeks

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

active comparator: Group 6 Eylea 6 weeks

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

active comparator: Group 7 Lucentis 8 weeks

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

active comparator: Group 8 Avastin 8 weeks

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

active comparator: Group 9 Eylea 8 weeks

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

active comparator: Group 10 Control Group no treatment

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

Interventions

Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.

Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.

Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.

Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.

Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care

Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care

Ranibizumab

Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care

Bevacizumab

Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care

Aflibercept

Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care

Control Group

Control group Subjects will no previous anti-VEGF treatment

Primary outcome measure

  • Change in serum and plasma levels of free Vascular Endothelial Growth Factor [ Time Frame: up to 8 weeks ]

Central Contacts and Locations

Central contacts

Ronald E. Frenkel, MD

772.287.9000info@efei.com

Locations

East Florida Eye Institute

Recruiting

Stuart, Florida, United States, 34994

Contacts

Ronald E. Frenkel, MD

772-287-9000info@efei.com

More Information

Sponsor

East Florida Eye Institute

Last update posted

Aug 11, 2015

Last verified

Aug, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by East Florida Eye Institute on 2015-08-11.