Phase 3
Completed N=650
Randomized Study for Efficacy and Safety of Ranibizumab 0.5mg in Treat-extend and Monthly Regimens in Patients With nAMD
Age-Related Macular Degeneration · Choroidal Neovascularization
Source: ClinicalTrials.gov NCT01948830 ↗
Enrolled (actual)
650
Serious AEs
12.5%
Results posted
Dec 2016
Primary outcomePrimary: Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 — 6.2; 8.1 Letters (EDTRS) — p=<0.001
◆ Published Evidence
Highly cited
137citations · ~23 / year
Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration.
Summary
This study was designed to evaluate the efficacy and safety of two different regimens of 0.5 mg ranibizumab given as intravitreal injection in patients with neovascular age-related macular degeneration
Linked Publications (3)
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Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration.
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SYSTEMATIC CORRELATION OF CENTRAL SUBFIELD THICKNESS WITH RETINAL FLUID VOLUMES QUANTIFIED BY DEEP LEARNING IN THE MAJOR EXUDATIVE MACULAR DISEASES.
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Effect of posterior vitreous detachment on treat-and-extend versus monthly ranibizumab for neovascular age-related macular degeneration.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 |
6.2; 8.1 | <0.001 sig |
| SECONDARY Number of Visits Scheduled |
8.9; 11.2 | — |
| SECONDARY Change in BCVA From Baseline to Month 12 |
6.4; 8.0 | — |
| SECONDARY Average BCVA Change From Baseline to Month 12 |
6.3; 7.1 | — |
| SECONDARY Mean Change in Visual Acuity BCVA (Letters) From Baseline to Month 12 |
4.6; 4.2; 5.5; 5.8; 6.7; 6.7 | — |
| SECONDARY Number of Patients With a BCVA Improvement of ≥1, ≥5, ≥10, ≥15, and ≥30 Letters From Baseline to Month 12 |
235; 233; 145; 145; 65; 58 | — |
| SECONDARY Number of Patients With Best Corrected Visual Acuity (BCVA) Loss <5, <10, and <15 Letters by Visit |
296; 295; 313; 314; 319; 320 | — |
| SECONDARY Number of Patients With a BCVA Value of ≥ 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 |
106; 106; 74; 136; 67; 148 | — |
| SECONDARY The Mean Number of Treatment Frequency |
8.7; 11.0 | — |
| SECONDARY The Average Number of Days Between Injections |
40.3; 29.4 | — |
| SECONDARY Percentage of Participants With Fluid Free Macula Over Time up to Month 12 |
60.5; 60.7; 39.5; 39; 0.0; 0.3 | — |
| SECONDARY Change in Central Subfield Retinal Thickness (CSFT) Over Time |
-137.6; -126.8; -151.6; -149.2; -149.8; -151.8 | — |
| SECONDARY Percentage of Patients With Choroidal Neovascularization (CNV) Leakage Assessed by Fluorescein Angiography (FA) in the Study Eye at |
18.7; 17.1; 74.1; 76.9; 0.0; 2.4 | — |
| SECONDARY Change From Baseline in Composite Score of the National Eye Institute-Visual Function Questionnaire-25 (NEI-VFQ-25) |
2.3; 4 | — |
Eligibility Criteria
Key Inclusion Criteria
- Male or female patients, ≥50 years of age with signed informed consent before study procedures
- Visual impairment predominantly due to nAMD.
- Active CNV secondary to AMD confirmed by presence of active leakage from CNV seen by fluorescein angiography (FA) and/or color fundus photography
- Presence of intra- or subretinal fluid/hemorrhage seen by SD-OCT
- BCVA score must be ≤ 78 and ≥ 23 letters at 4 meters starting distance using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity charts (approximate Snellen equivalent of 20/32 and 20/320)
Key Exclusion Criteria
- Any type of advanced, severe or unstable disease, including any medical condition (controlled or uncontrolled) that could be expected to progress, recur, or change to such an extent that it may bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk.
- Stroke or myocardial infarction within 3 months prior to Screening.
- Any active periocular or ocular infection or inflammation in both eyes.
- Ocular disorders in the study eye at the time of enrollment that may confound interpretation of study results and compromise visual acuity.
- Presence of amblyopia or amaurosis in the fellow eye.
- History of treatment with any anti-angiogenic drugs (including any anti- vascular endothelial growth factor (anti-VEGF) agents) e.g., bevacizumab [Avastin®], aflibercept [Eylea®]) or vPDT in the study eye.
- History of intravitreal treatment with corticosteroids within 6 months and history of intra-ocular surgery within 3 months in the study eye prior to the Screening.
- Pregnant or nursing (lactating) women. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment.
Data sourced from ClinicalTrials.gov (NCT01948830) and the linked publication. 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.