UNcovering the Difference Between Ranibizumab and Aflibercept, Focusing on Systemic Anti-vascular Endothelial Growth Factor (VEGF) Effects in Patients With neovascuLar Age-related Macular Degeneration (AMD)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

205 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-09-30

Brief Summary

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This study assessed systemic vascular endothelial growth factor (VEGF) level in patients with neovascular Age-related Macular Degeneration following treatment with Ranibizumab or Aflibercept.

Free plasma VEGF-A level was measured in this study .

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Detailed Description

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Conditions

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Neovacular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ranibizumab

104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection adminstered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Group Type EXPERIMENTAL

Neovascular Age-related Macular Degeneration

Intervention Type PROCEDURE

Blood measurement

Aflibercept

101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection admistered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).

Group Type ACTIVE_COMPARATOR

Neovascular Age-related Macular Degeneration

Intervention Type PROCEDURE

Blood measurement

Interventions

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Neovascular Age-related Macular Degeneration

Blood measurement

Intervention Type PROCEDURE

Other Intervention Names

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Lucentis, Eylea

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed Age-related Macular Degeneration (AMD)
* No previous treatment received for diagnosed AMD
* Visual Acuity 6/7.5 to 6/96

Exclusion Criteria

* Visual Acuity \<6/96
* nAMD in both eyes, or any condition in other eye which may have required anti- VEGF treatment during study period
* other disease in candidate eye which could have compromised visual acuity or required medical/surgical intervention during study period
* participation to other clinical study with 'not approved' treatment within a year prior to UNRAVEL study participation.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No