Phase 4
Completed N=205
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)
Neovacular Age-related Macular Degeneration
Source: ClinicalTrials.gov NCT01988662 ↗
Enrolled (actual)
205
Serious AEs
3.9%
Results posted
Feb 2017
Primary outcomePrimary: Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent — 41.04; -21.53 Percent change — p=0.012
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
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 .
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline at Month 3 in Plasma VEGF Following Intravitreal (IVT) Injection of Anti-VEGF Agent |
41.04; -21.53 | 0.012 sig |
| SECONDARY Percent Change From Baseline in Plasma VEGF Level Overtime |
11.93; -9.37; 44.08; -7.44; 38.76; -16.45 | — |
| SECONDARY Correlation Between Percent Change From Baseline Plasma VEGF Level and the Serum Anti-VEGF Agent Overtime |
-0.141; 0.083; 0.027; 0.234; -0.085; 0.192 | — |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) of the Study Eye Over Time |
3.9; 2.8; 5.8; 5.1; 6.1; 6.9 | — |
| SECONDARY Mean Change From Baseline in Central Retinal Thickness (CRT) of the Study Eye Over Time |
-75.0; -93.8; -94.3; -116.6; -93.7; -124.3 | — |
| SECONDARY Number of Patients With Ocular and Systemic Adverse Events |
32; 32; 3; 5; 0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01988662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.