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) (UNRAVEL)

Novartis

Status and phase: Completed; Phase 4

Conditions: Neovacular Age-related Macular Degeneration

Treatments: Procedure: Neovascular Age-related Macular Degeneration

Study type: Interventional

Funder types: Industry

Identifiers

NCT01988662

2013-003482-34 (EudraCT Number)

CRFB002A-MAX-IL-01

Details and patient eligibility

About

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 .

Enrollment: 205 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria

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

Key Exclusion Criteria:

• standard exclusion criteria for anti-VEGF treatment
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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205 participants in 2 patient groups

Ranibizumab

Experimental group

Description:

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).

Treatment:

Procedure: Neovascular Age-related Macular Degeneration

Aflibercept

Active Comparator group

Description:

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).

Treatment:

Procedure: Neovascular Age-related Macular Degeneration