Phase 4
Completed N=712
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
Source: ClinicalTrials.gov NCT01958918 ↗Enrolled (actual)
712
Serious AEs
19.8%
Results posted
Mar 2019
Primary outcomePrimary: Mean of the Absolute Values of CSRT Difference Month 3 to Month 6 — 25.16; 29.28 micrometers — p=0.1850
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean of the Absolute Values of CSRT Difference Month 3 to Month 6 |
25.16; 29.28 | 0.1850 |
| SECONDARY Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12 |
66.4; 68 | — |
| SECONDARY IREST at Month 12 |
5.7; 6.1 | — |
| SECONDARY National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12 |
80.0; 79.1 | — |
| SECONDARY Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set) |
-0.2194; 0.0155; 0.0889; 0.0450; 0.1064; 0.0847 | — |
Eligibility Criteria
Key Inclusion Criteria
- Visual impairment predominantly due to neovascular AMD Active
- Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
Key Exclusion Criteria
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
- Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
Data sourced from ClinicalTrials.gov (NCT01958918). 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.